Priority medicines for MPP licensing
Focusing efforts on key health products to achieve the greatest public health impact in LMICs
The mission of the Medicines Patent Pool (MPP) is to facilitate the development of- and increase access to, life-saving medicines and health technologies for low- and middle-income countries (LMICs) through public-health oriented voluntary licensing and technology transfer. To do so, the first step for MPP is to identify suitable candidates using a prioritisation framework that is applied to assess products of potential interest in all health areas.
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SUMMARY
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ALL HEALTH AREAS
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HIV
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TUBERCULOSIS
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VIRAL HEPATITIS
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PANDEMIC & EPIDEMIC THREATS
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FOCUS ON CHILDREN
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ONCOLOGY
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DIABETES, CARDIOVASCULAR & METABOLIC DISORDERS
MPP’s list of priority and watchlist products is regularly updated, by following a peer-reviewed prioritisation framework. It outlines the health areas on which MPP focuses its activities.
MPP’s prioritisation list includes medicines and health technologies for which expanded access in LMICs could provide significant health benefits over standards of care, and where a voluntary agreement, including licensing and/or technology transfer, through MPP could lead to substantial public health impact.
This prioritisation process contributes to ensuring MPP focuses its efforts on medicines for which licensing could have the greatest public health impact. By using a robust framework, MPP evaluates product candidates and publishes a list of prioritised and watchlist medicines and health innovations in a range of health areas, for which a potential MPP intervention may support increased access.
It should be noted that MPP does not include in its prioritisation list the medicines and health innovations for which it has already signed agreements. The list of MPP previously signed agreements to enable access are available on the “agreements with innovators” section of MPP’s website.
HIV
TUBERCULOSIS
VIRAL HEPATITIS
VIRAL HEPATITIS C
VIRAL HEPATITIS B
PANDEMIC & EPIDEMIC THREATS
INFLUENZA
FOCUS ON CHILDREN
RESPIRATORY SYNCYTIAL VIRUS
MALARIA
LOW-GRADE GLIOMAS
CYSTIC FIBROSIS
HIV POST-NATAL PROPHYLAXIS
DIABETES, CARDIOVASCULAR & METABOLIC DISORDERS
DIABETES & OBESITY
CARDIOVASCULAR & METABOLIC DISORDERS
ONCOLOGY
MULTIPLE CANCER INDICATIONS
LUNG CANCER
BREAST CANCER
CHRONIC LYMPHOCYTIC LEUKAEMIA
PROSTATE CANCER
OTHER CANCER INDICATIONS
In 2024, 39.9 million people were living with HIV worldwide, with only 30.7 million persons accessing antiretroviral therapy. HIV paediatric care is improving, but still only 57% of children living with the virus had access to treatment, compared to 77% for adults. With 1.3 million people acquiring HIV annually, prevention is also key to tackle the transmission. Although pre-exposure prophylaxis (PrEP) has proven efficient in preventing HIV infection, its uptake is still slow.
Affordable and effective HIV medicines are imperative, especially for people living with HIV (PLHIV) in low- and middle-income countries (LMICs) where HIV is most prevalent. Medicines must also be available in the right formulations. Fixed-dose combinations and long-acting formulations can contribute to improving adherence. Specially formulated treatments for children, appropriate for different weights and developmental stages, improve care.
Since 2010, we have worked with leading HIV drug manufacturers, governments, international organisations, civil society, and affected communities to improve access to World Health Organization (WHO) prioritised and recommended medicines for people living with HIV in LMICs. We have also worked to increase access to HIV prevention tools and supported the diversification of prevention options. In 2022, MPP signed a voluntary licensing agreement with ViiV Healthcare for cabotegravir long-acting (LA) for HIV PrEP. This is an important step in accelerating affordable and equitable access to the first approved injectable long-acting PrEP recommended by WHO in up to 142 countries .
There is increasing interest in long-acting therapeutics for both PrEP and HIV treatment, given their potential benefits in terms of efficacy (including through support of improved adherence), and user experience (including convenience and discretion). Ongoing changes related to the impact of international funding cuts on the global health landscape will also require additional performance and further efficiencies from HIV programmes in LMICs, necessitating continued efforts for the development and rollout of HIV prevention and treatment innovations, with clear roles for long-acting and ARV-sparing regimens in reaching more people effectively and managing increasingly scarce resources more efficiently.
Cabotegravir (CAB) is the only approved long-acting integrase strand transfer inhibitor (INSTI). In combination with the non-nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine (RPV), it forms the only approved fully long-acting HIV treatment regimen. This regimen is currently approved by several national regulatory authorities for use in virologically suppressed adults with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine, administered monthly or every 2 months. Despite its benefits, including for use in LMICs, the injectable CAB+RPV regimen is currently not included in WHO guidelines for HIV treatment.
Compared to daily oral antiretroviral therapy (ART), CAB+RPV could support the improvement of adherence to treatment, achieve and maintain virologic suppression. However, there may be concerns about the suitability of the use of this regimen in specific populations with co-infections (see below). One key issue for implementation in resource-limited settings is that rilpivirine—not cabotegravir—requires a cold chain for storage. Additionally, rilpivirine’s low barrier to resistance raises concerns about the long-term effectiveness of the NNRTI class in case of clinical resistance to the drug.
For people living with both HIV and hepatitis B (HBV), switching from a tenofovir disoproxil fumarate (TDF) or tenofovir alafenamide (TAF)-containing regimen—such as the widely used oral tenofovir/lamivudine/dolutegravir (TLD)—to dual regimens, including CAB+RPV, would remove the HBV-suppressive effects of TDF or TAF, potentially worsening HBV management in people living with both HIV and HBV. Furthermore, drug-drug interactions between CAB+RPV and tuberculosis (TB) treatments, such as rifampicin and rifabutin, pose additional concerns for individuals living with both HIV and TB.
Data indicate that people facing adherence challenges to daily oral treatment, who switched to long-acting injectable CAB+RPV experienced greater viral load reductions than those remaining on daily oral ART. More recently, findings from the CARES study in 3 countries in sub-Saharan Africa demonstrated that switching to CAB+RPV was non-inferior to continuing oral ART, with high rates of HIV-1 RNA suppression at week 96. This study marks an important milestone, highlighting the potential clinical feasibility and effectiveness of long-acting injectable HIV treatment in LMICs.
Long-acting cabotegravir for HIV PrEP was licensed to MPP in 2022. With RPV patents expected to expire in 2027, and the formulation of cabotegravir being the same for PrEP and for treatment indications, in least developed countries, the expansion of the ViiV-MPP licence for cabotegravir long-acting for PrEP to also cover the treatment indication, could open the possibility for generic CAB+RPV LAI in LMICs, and potentially in the future, to other cabotegravir-based long-acting regimens for HIV treatment, if companion drugs also benefit from appropriate access programs.
Patent & licence data for cabotegravir in LMICs
Lenacapavir is a capsid inhibitor with a novel mechanism of action, distinguishable from other currently approved classes of antiviral agents, as it inhibits HIV at multiple stages of its lifecycle and has no known cross resistance exhibited in vitro to other existing drug classes. Lenacapavir has received regulatory approvals in Europe and 10 high-income countries as a treatment for adults with multi-drug resistant HIV, intended for use in combination with other antiretroviral medications. It is also awaiting approval for use in the context of HIV prevention.
Lenacapavir primary patents have been filed or granted in several LMICs and are expected to expire between 2034 and 2037. Gilead also holds secondary patents that may provide exclusivity until 2038 in many LMICs. Gilead has signed bilateral voluntary licence agreements with six generic manufacturers, allowing for sales of lenacapavir for HIV prevention and treatment of heavily treatment-experienced adults with multi-drug-resistant HIV in 120 countries. LMICs beyond the licence territory will not have access to the generic products via these agreements.
An approved long-acting companion medicine allowing for a fully long-acting lenacapavir-based treatment regimen is still missing, and lenacapavir is being evaluated as a long-acting option in multiple ongoing and planned early and late-stage clinical studies of potential fully long-acting HIV treatment regimens. Of notice, the current voluntary licence does not cover a broad treatment indication. Given the prominent role such regimens could play in the future, and remaining uncertainties surrounding lenacapavir’s future accessibility and affordability in LMICs for both treatment and prevention indications, including the possibility of expanding the geographical scope and indication of the licensing agreements, lenacapavir remains a priority for MPP.
Two potential HIV treatment regimens currently stand out as priorities for MPP licensing: lenacapavir with either cabotegravir or islatravir, based on relevant data as it is being generated. The possibility of the addition of a regional manufacturer for lenacapavir in countries with high HIV prevalence in sub-Saharan Africa would also be worth exploring.
Lenacapavir for PrEP
Lenacapavir is a candidate for long-acting pre-exposure prophylaxis (PrEP) through a twice-yearly subcutaneous injection, following an initial oral loading phase. Gilead has submitted marketing authorisation applications to EMA (for both EU MAA and EU-M4all) and to the FDA. Results from the PURPOSE 1 and PURPOSE 2 phase III trials have demonstrated high effectiveness in preventing HIV, with mostly mild injection site reactions such as pain, nodules, and indurations . Additionally, recent data confirm lenacapavir’s safety and efficacy in adolescents, broadening its potential impact on containing the HIV epidemic if rolled out extensively.
At CROI 2025, groundbreaking findings on new intramuscular formulations of lenacapavir were presented, featuring two single-dose injections designed for annual administration. These formulations were safe and tolerable in the study participants, and maintained plasma drug concentrations above the 95% effective threshold for at least 56 weeks, highlighting the feasibility of extending dosing intervals even further. If successful in follow-up trials, adjusted yearly injections could represent a significant shift in HIV prevention strategies. If affordable and accessible, this candidate could represent a very powerful tool to contain the global HIV epidemic. It is not known whether this formulation is captured under the Gilead voluntary licence for lenacapavir.
Lenacapavir for treatment
Lenacapavir is currently approved by several stringent regulatory authorities for the treatment of HIV-1 infection in heavily treatment-experienced adults whose current antiretroviral regimen is failing due to resistance, intolerance, or safety concerns. Lenacapavir’s low administration frequency and long-acting nature could offer a paradigm shift also in treatment.
A phase II clinical study investigated the efficacy of a weekly oral combination of lenacapavir and islatravir. The study demonstrated strong virologic suppression without negatively affecting lymphocyte counts. These results have prompted the initiation of two phase III trials , which are evaluating a weekly oral fixed dose combination of islatravir and lenacapavir in virologically suppressed persons living with HIV. The research supports broader efforts to develop more convenient, decentralized HIV treatment options that could improve access while supporting increased adherence.
Lenacapavir is also under investigation in combination with cabotegravir (with or without rilpivirine) for individuals with NNRTI resistance. A small case-series showed high rates of virologic suppression in people with HIV on a LEN+CAB regimen, highlighting its potential as a long-acting injectable option for people with limited treatment choices. However, additional research is needed to confirm safety, efficacy, durability, and resistance barriers. A multicentric clinical trial assessing the use of LEN+CAB for HIV treatment in comparison to standard of care is in planning stages.
Additionally, lenacapavir is being explored in combination with once-daily bictegravir as a possible simplified regimen for people with HIV who require complex treatment due to previous resistance or treatment failures.
However, accessibility remains a challenge—lenacapavir is not yet registered for the treatment indication in LMICs, limiting its availability to those who may benefit most from this alternative in a treatment regimen.
Patent & licence data for lenacapavir in LMICs
1 Priorities for antiretroviral drug optimization in adults and children report of a CADO, PADO and HIVResNet joint meeting (accessible here).
MK-8527 is an investigational nucleoside reverse transcriptase translocation inhibitor (NRTTI) being developed for the prevention of HIV. MK-8527 shares mechanistic similarities with islatravir, offering the potential for high potency and a strong genetic barrier to resistance. MK-8527 is a promising clinical candidate for HIV PrEP, being evaluated for once-monthly oral dosing. The phase IIa study to assess safety, tolerability, and pharmacokinetics of oral MK-8527 once monthly was just completed, while a larger PK/PD study has just started. Of notice, a specific trial is also planned, evaluating the drug PK in breast milk and blood of breastfeeding individuals. MK-8527 primary patents with an expected expiry in 2034 have been granted to MSD in at least 35 LMICs and are pending in another 13 countries. Secondary patent filings are anticipated.
Islatravir is a first-in-class nucleoside reverse transcriptase translocation inhibitor (NRTTI) that is not yet approved. After a temporary pause in clinical development due to safety concerns, Merck has resumed selected islatravir programs with close safety monitoring.
Recent phase III studies have demonstrated that islatravir, when administered as a once-daily oral treatment in combination with doravirine (DOR/ISL 100 mg/0.25 mg), is both safe and non-inferior to commonly used antiretroviral therapy (ART) regimens in virologically suppressed individuals with HIV-1.
Additionally, islatravir is being investigated as a fixed dose combination with lenacapavir as weekly oral treatment (see also above in the lenacapavir section). If successful, an oral long-acting HIV treatment could provide an important alternative, particularly in settings focused on decentralized service delivery.
Patents on islatravir compound and its use for treating HIV – owned by Yamasa corporation and licensed exclusively to MSD – were mainly filed in HICs and Mexico and were expected to expire on 24.03.2025. A patent family covering the use of Islatravir for the treatment or prophylaxis of HIV (dosing regimen less frequent than once-daily) owned by MSD includes patent applications filed in several LMICs countries/regions with an expected expiry in February 2037.
GS-1720 is an investigational once-weekly oral INSTI being evaluated for treatment in both treatment-naïve and switch populations of people living with HIV. GS-1720 is studied in combination with GS-4182, a new oral lenacapavir prodrug with improved bioavailability. Phase II/III WONDERS trials are currently underway using the GS-1720+GS-4182 combination.
If successful, a weekly oral HIV treatment could provide a valuable alternative for PLHIV.
Gilead primary patent applications on GS-1720 have been filed in about 47 LMICs with an expected expiry in 2042. Further secondary patent filings are anticipated.
GS-4182 is an investigational lenacapavir prodrug with improved bioavailability and potential for oral weekly administration. GS-4182 is studied in combination with GS-1720, a new oral INSTI. Phase II/III WONDERS trials are currently underway using the GS-4182+GS-1720 combination. In December 2022, Gilead filed three international patent applications covering lenacapavir pro-drugs, which may include GS-4182. Confirmation will be possible once the chemical structure of GS-4182 is available in the public domain. The expected expiry of the compound patents is 2042, and additional secondary patent filings are anticipated. If successful, a weekly oral HIV treatment could provide a valuable alternative for PLHIV.
Cabotegravir 4-monthly, also called CAB-ULA (ultra long-acting) is an investigational longer-acting formulation of cabotegravir that demonstrates a pharmacokinetic (PK) profile supporting dosing intervals of approximately four months. This extended dosing schedule has the potential to reduce clinic visits and improve adherence. Early data suggest a favourable safety profile, with intramuscular (IM) administration being better tolerated than subcutaneous (SQ) injection. As a result, CAB-ULA IM dosed every four months is advancing into late-stage studies investigating its use for both HIV-1 PrEP and treatment.
For PrEP, the EXTEND 4M registration trial is evaluating a single IM injection of CAB-ULA at 1600 mg/3mL. The FDA has approved this registration strategy, based on PK bridging studies, without requiring an additional efficacy study. The trial was launched in December 2024 and is expected to reach its primary endpoints by Q3 2026.
For HIV treatment, a phase III registration trial is evaluating CAB-ULA combined with rilpivirine (RPV) at Q4M dosing, following the completion of phase I studies on multiple formulations.
Primary patents on cabotegravir have been granted in many LMICs and are expected to expire in 2026. A secondary patent on the 4-monthly formulation was published in March 2025. The corresponding international patent application is pending, and geographical coverage in LMICs is expected to be available by March 2026, with patents anticipated to expire in 2043.
Doravirine (DOR) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) approved for use in combination with other antiretroviral agents for the treatment of HIV-1 in adult patients with no prior antiretroviral treatment history. It is being investigated for HIV treatment in combination with islatravir as once daily oral treatment. However, the evidence of clinical benefits over the standard of care is still unclear.
Primary patents on doravirine compound and its combinations with other anti-HIV agents have been filed in many LMICs and are expected to expire in 2031. In few countries, the patent term may be extended by another five years, until 2036. While bilateral voluntary licences have been granted to generic manufacturer for 86 countries, public information on such licences is limited. The existing licence for DOR may enable access to generics of DOR+3TC in 86 LMICs; however, the development status for licensed generic DOR versions is unknown.
This insert is a candidate tenofovir alafenamide/elvitegravir (TAF/EVG) insert fast-dissolving, bullet-shaped tablet for vaginal or rectal administration for on-demand HIV prophylaxis (both PrEP and post-exposure prophylaxis, PEP). The insert contains a co-formulation of antiretroviral drugs that dissolve upon insertion, preventing HIV replication locally. This candidate passed several phase I studies and is currently collecting more data on safety and PK for both administration routes . It is awaiting to enter phase II to continue assessing safety and effectiveness. As this phase II study was planned in the context of the USAID-funded MATRIX project, the progress of this promising prevention candidate that could complement other existing tools is currently paused.
CONRAD have filed for patents on their TAF/EVG sustained release formulation for vaginal or rectal use in 7 LMICs, including South Africa. If granted, these would likely expire in 2039. If successful, this product could complement other PrEP and PEP options, serving clients of any gender for whom a discreet, user-initiated, event-driven HIV prevention method would be appealing. The manufacturing prospects indicate a potential low-price for quality assured generic versions if a voluntary licence agreement is reached.
Ulonivirine (previously known as MK 8507) is an orally-administered investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) being developed by MSD for the treatment of HIV-1 infection. Its pharmacokinetic profile supports once-weekly oral administration, which could improve adherence. It is currently being studied in combination with islatravir in a once-weekly oral regimen for maintaining viral suppression. Its potential for less frequent dosing and use in combination therapy makes it a promising candidate for HIV treatment. Ulonivirine compound patents are granted in many LMICs, including India, with an expiry date expected by 2033.
VH4524184 is a third-generation INSTI, with a superior resistance profile. It could be important in cases of future INSTI resistance.
VH4524184 is a phase II third-generation integrase strand transfer inhibitor (INSTI) administered by injection, with a superior resistance profile compared to second-generation INSTIs. It could be important in case of increasing DTG resistance. The chemical structure of VH4524184 is not available in the public domain. Similarly, no patent information is available yet, however patent filings are to be expected.
ViiV’s new capsid inhibitor demonstrated promising phase IIa data, with oral doses ranging from 25 mg to 250 mg every five days in ART-naïve individuals. By day 11, virologic suppression was observed. The drug is planned for development as an injectable long-acting (LA) therapy. The chemical structure of VH4011499 is not available in the public domain. Similarly, no patent information is available yet, however patent filings are to be expected.
These laboratory-made proteins emulate the immune system’s ability to counteract harmful pathogens, including HIV. Although still in the early stages of development, broadly-neutralising antibodies demonstrate significant potential for use as HIV post-natal prophylaxis (PNP), due to their favourable safety profile and the convenience they may offer through a single administration covering the peri-natal and breastfeeding period via intramuscular injection,,. Despite potential benefits, crucial clinical data on the efficacy of monoclonal antibodies for PNP remain lacking. Specifically, there is a notable gap in understanding whether a single monoclonal antibody could suffice for prevention. If multiple mAbs are necessary, the cost could become a significant concern, especially when compared to cheaper small molecules.
Beyond their use in postnatal prophylaxis, broadly neutralizing antibodies (bNAbs) are also being investigated for HIV cure strategies. The RIO study explored the use of two antibodies that can complementarily neutralize HIV through distinct mechanisms of action (3BNC117 and 10-1074, also known as teropavimab and zinlirvimab) in cis-gender men participants who accepted to stop their HIV-antiretroviral treatment, indicating that a one-time infusion of this antibodies combination could sustain viral suppression for over a year in some participants . While these findings remain preliminary, they highlight the broader therapeutic potential of bNAbs beyond postnatal prophylaxis.
TB is present in all countries and age groups. An estimated global total of 10.8 million people fell ill with tuberculosis (TB) in 2023, including 1.3 million children, most in low- and middle-income countries 1.
TB is the leading cause of death for people with HIV and a major contributor to antimicrobial resistance. In 2023, 1.25 million people died from TB, including 161 000 people with HIV.
Multidrug-resistant TB (MDR-TB) remains a public health crisis and a health security threat. Only about 2 in 5 people with drug resistant TB accessed treatment in 2023.
However, TB is curable and preventable.
Global efforts to combat TB have saved an estimated 79 million lives since the year 2000. It is estimated that US$ 22 billion are needed annually for TB prevention, diagnosis, treatment and care to achieve the global target by 2027 agreed at the 2023 UN high level-meeting on TB. Ending the TB epidemic by 2030 is among the health targets of the United Nations Sustainable Development Goals (SDGs).
More optimized therapies to treat TB are urgently needed, particularly for MDR-TB.
We work to improve access to new treatments for MDR-TB and drug-susceptible tuberculosis, as well as facilitating development of innovative combinations allowing for shorter/optimized treatment courses, including for tuberculosis preventative therapies (TPT), by licensing TB drugs that are still under development.
In early 2017, MPP signed its first agreement with the Johns Hopkins University 2. This agreement was to facilitate the clinical development of sutezolid, a promising investigational treatment for tuberculosis. It was followed by a second agreement with Pfizer in October 2019 to access Pfizer’s preclinical, phase I and phase IIa clinical study data and results on sutezolid 3. The agreement’s aim was to further study, develop and make available this potential important component of new TB regimens.
Moreover, in 2021, MPP signed the first non-exclusive, worldwide, voluntary license agreement with Tandem Nano, a spin-off of University of Liverpool, for a long-acting TPT candidate, using injectable formulations of rifapentine and an isoniazid prodrug, developed by members of the LONGEVITY consortium, funded by Unitaid 4.
1 WHO - Global tuberculosis report 2024 (last accessed 22 March 2025)
2 MPP- Johns Hopkins University - Sutezolid -2017
3 MPP- Pfizer - Sutezolid -2019
4 MPP- TandemNano-LA-2021
Quabodepistat (previously known as OPC-167832) is a medicine with a new mechanism of action that has potent antituberculosis activity and a favourable safety profile. Despite premature termination of PAN-TB Consortium trials including quabodepistat - since the trial does not support the investigational regimens being able to achieve the trial objective of identifying a new regimen to treat tuberculosis in 3 months or less - Otsuka plans to study the drug with bedaquiline and delamanid in phase III trials. The primary patent on quabodepistat has been granted in more than 50 LMICs and is expected to expire in 2035. There are secondary patents on intermediates and combinations that may provide exclusivity until 2037-2039 in many LMICs.
Alpibectir functions through a unique mechanism that targets bacterial transcriptional regulators, activating novel bioactivation pathways for ethionamide (Eto). Eto is an older, well-known anti-TB drug, but its use at high concentrations is limited due to significant side effects. By enhancing Eto’s efficacy, alpibectir enables its use at lower, non-toxic concentrations, potentially improving its safety profile while maintaining therapeutic effectiveness. Alpibectir is in phase II. Primary patents on alpibectir have been filed in many LMICs and are expected to expire in 2038.
Bedaquiline is a crucial antibiotic for treating TB, particularly MDR-TB. It significantly improves treatment outcomes by reducing mortality and shortening therapy duration compared to older, less effective, often injectable, regimens. A long-acting formulation of bedaquiline could be useful as a new modality to increase adherence in the treatment of latent TB infection (LTBI, also known as TB preventive treatment, TPT), which is recommended by WHO for people living with HIV, household contacts of people with TB, and other risk groups. Bedaquiline long-acting is in phase I and data on safety and efficacy are still immature. Although the compound patent expired in 2023, Janssen owns several patents in LMICs on long-acting formulations of bedaquiline expiring between 2038 and 2041.
Delpazolid is an investigational antitubercular agent. It is being studied in combination with delamanid and bedaquiline. Delpazolid is a promising oxazolidinone antibiotic being developed for the treatment of TB. Currently in phase II clinical trials, delpazolid has demonstrated improved efficacy and safety compared to linezolid. The recently completed DECODE phase IIb trial evaluated different doses of delpazolid (up to 1200mg once daily) in combination with a backbone regimen of bedaquiline, delamanid, and moxifloxacin for the treatment of pulmonary TB. The study found that delpazolid was safe and well-tolerated, while promising signs of efficacy for drug-sensitive TB. However, the trial had limitations, including a small sample size that resulted in wide confidence intervals and the absence of a standard of care control arm for comparison. Despite these limitations, the trial results suggest delpazolid could be a strong candidate for treating drug-resistant TB. As the clinical data are still immature, the drug candidate remains in the watchlist. The primary patent on delpazolid is filed or granted in key countries of manufacture such as India, China and South Africa and is expected to expire in 2029. Secondary patents with an expected expiry date in 2031 are filed or granted in a few LMICs.
Ganfeborole (GSK3036656) is an investigational agent, demonstrating early bactericidal activity with a low, once-daily oral dose after 14 days of treatment in participants with drug-susceptible pulmonary tuberculosis . While ganfeborole is highly potent and effective at low doses, it may pose a risk of teratogenicity . It is in phase II and data are still immature and therefore the drug candidate remains in the watchlist. Patents on the compound have been filed or granted in several LMICs and are expected to expire between 2031-2036. Additional secondary patents may be filed.
Macozinone (PBTZ-169) is a tuberculosis drug candidate that has demonstrated high potency against drug-susceptible and drug-resistant TB in preclinical studies. Macozinone has additive effects with many TB therapeutic agents, both marketed and in development, and has synergic effects with bedaquiline and clofazimine in preclinical models . As macozinone is in phase II, data are still immature and the drug candidate remains in the watchlist. Primary patents on macozinone have been granted in key countries of manufacture such as India, China and South Africa and are expected to expire in 2031. Secondary patents may be filed.
Sudapyridine (WX-081) is a new agent being studied for TB with a mechanism of action similar to bedaquiline, functioning as an ATP synthase inhibitor. It could be important for MDR-TB, which remains a major global health challenge. Sudapyridine has the potential to reduce some of the side effects observed with bedaquiline (such as cardiac issues with prolonged QT intervals, or liver toxicity and gastrointestinal issues). It is currently in phase III of development in patients with rifampicin-resistant pulmonary tuberculosis. Primary patents on sudapyridine are present in key countries of manufacture such as India, China and South Africa and are expected to expire in 2035. Secondary patents covering manufacturing processes and intermediates with an expected expiry date in 2037 are present in a few LMICs.
In 2022, viral hepatitis claimed approximately 1.3 million lives, of which 83% were attributed to hepatitis B and 17% to hepatitis C. New infections decreased from 3 million in 2019 to 2.2 million in 2022 (1.2 million hepatitis B, 1.0 million hepatitis C). Despite this progress, the global burden remains substantial with 304 million people living with viral hepatitis in 2022 (254 million with hepatitis B, 50 million with hepatitis C).
Children represent 12% of the hepatitis burden, primarily affecting those with hepatitis B. Significant regional disparities persist, with the WHO African Region accounting for 63% of new hepatitis B infections, yet only 18% of newborns in this region receive the hepatitis B birth-dose vaccine. The Western Pacific Region reports 47% of hepatitis B deaths, with inadequate treatment coverage.
Although hepatitis C is curable, identifying populations living with the virus remains challenging due to limited awareness and screening programs. High-cost diagnostic tools and the requirement for confirmatory molecular diagnostics represent key barriers to treatment access. There is an urgent need for well-tolerated, highly effective pangenotypic cure regimens requiring less frequent administration.
Hepatitis B, while preventable through vaccination, maintains high prevalence rates. Beyond improved diagnostics, treatments that could provide a functional cure for hepatitis B are essential to reduce long-term disease burden, management costs, and complications. Expanded prevention, screening, and treatment initiatives are critical to address the global hepatitis crisis. Currently, few LMICs have committed to hepatitis elimination goals, and additional funding for effective diagnostic and care implementation is urgently needed.
MPP collaborates with diverse stakeholders—including originator and generic companies, governments, WHO, civil society, communities, procurement agencies, and clinical experts—to accelerate development and distribution of new treatments for eliminating HCV through shorter, more effective therapies in LMICs with high viral hepatitis burden. MPP’s multilateral engagements increase awareness of WHO-recommended treatment options available through MPP licenses (including TDF, TAF, DAC, and DAC/SOF combinations) and support increased uptake of quality-assured, affordable treatments in LMICs.
Notably, MPP’s work also addresses HBV through licensed TDF and TAF treatments, benefiting people living with HIV who receive TDF and TAF-based regimens with diagnosed or undiagnosed HBV, as well as individuals using oral PrEP containing TDF or TAF. Through these licenses, MPP supports the WHO strategy for triple elimination of vertical transmission of HIV, syphilis, and hepatitis B.
MPP closely monitors the evolving viral hepatitis therapeutics R&D pipeline (for hepatitis B, C, and D) , in collaboration with leading experts to assess potential MPP interventions for leading candidates. Currently, three medicines (including investigational medicines) are included in the watchlist. With the currently available data, no viral hepatitis therapies have been identified as priority candidates for which an MPP agreement would achieve significant impact.
VIRAL HEPATITIS C
Bemnifosbuvir is a nucleotide analog polymerase inhibitor designed to inhibit viral replication by impairing viral RNA polymerase. It has demonstrated potent pan-genotypic antiviral activity against HCV and has shown approximately 10-fold higher activity than sofosbuvir in vitro, while retaining efficacy against sofosbuvir-resistant strains. Bemnifosbuvir’s safety profile has been favorable, with a low risk of drug-drug interactions and no food effect reported. When combined with ruzasvir, an oral NS5A inhibitor, the two compounds have shown synergistic antiviral effects in vitro. The combination of bemnifosbuvir and ruzasvir has demonstrated a high sustained virologic response rate of 98% (208/213) at 12 weeks post-treatment (SVR12) after just eight weeks of treatment in a phase II study. This regimen offers potential advantages over existing treatments, including a short treatment duration (8 weeks), low risk of drug-drug interactions, and efficacy across HCV genotypes 1-4, positioning it as a promising new option for HCV therapy. Atea’s primary patents on bemnifosbuvir, expected to expire in 2036, have been granted in 35 LMICs and are pending in another 14 LMICs. Atea owns several secondary patents on salts and polymorphs that may provide exclusivity until 2038-2042, as well as combinations with ruzasvir until 2039-2042 in many LMICs.
Ruzasvir is an oral NS5A inhibitor that also exhibits potent pan-genotypic antiviral activity against HCV. When combined with bemnifosbuvir, the regimen showed a high sustained virologic response after a short treatment duration, with minimal drug interactions and broad efficacy across multiple HCV genotypes, making it a promising therapy option (see also above in the bemnifosbuvir section). Ruzasvir was first developed by MSD and exclusively licensed to Atea in 2021. Primary patents, expected to expire between 2031 and 2033, have been widely withdrawn and kept in force only in a few European countries. Atea filed two combination patents for bemnifosbuvir + ruzasvir. The second combination patent, expiring in 2042, is pending in 17 LMICs.