MPP’s Long-Acting Licence Portfolio

MPP has built a growing portfolio of long-acting licences that spans from approved flagship products to early-stage technologies. These agreements represent milestones in ensuring timely, affordable access to long-acting innovations in LMICs.

Cabotegravir Long-Acting (CAB LA) — ViiV Healthcare

The landmark licence for long-acting HIV prevention and treatment

In July 2022, ViiV Healthcare and MPP signed a voluntary licensing agreement for patents related to cabotegravir long-acting (CAB LA) for HIV pre-exposure prophylaxis (PrEP). This licence was signed seven months after the first regulatory approval of CAB LA for PrEP anywhere in the world. It is the first public-health oriented voluntary license for injectable HIV PrEP.

In October 2025, the agreement was expanded to also cover the use of cabotegravir LA for HIV treatment in 133 countries, coinciding with updated guidance from the WHO, recommending long-acting injectable cabotegravir + rilpivirine as an HIV treatment option. The agreement enables existing licensees, Aurobindo, Cipla and Viatris, to develop, manufacture and supply quality assured generic versions of CAB LA for both prevention and treatment in countries bearing the highest burden of the HIV epidemic.

This is the first public-health oriented voluntary licence for a long-acting HIV therapeutic, marking a major milestone in global access to innovative HIV medicines.

→ Access the CAB LA licence
→ Read the press release on the licence expansion for treatment
→ Read the press release on sublicences with Aurobindo, Cipla and Viatris

Early-Stage Long-Acting Technology Licences

As a proof of concept of the feasibility and relevance of early licensing in the long-acting space, MPP has worked closely with three innovators, whose work was supported through Unitaid grants. The licenses are relevant to three long-acting projects to accelerate the development of existing daily oral medicines into LA injectable versions to prevent malaria and TB and treat HIV and hepatitis C.

These licences represent milestones as the first-ever access-oriented agreements for long-acting technologies, specifically tailored for expanded access to infectious diseases life-saving commodities.

LONGEVITY Project — Tandem Nano Ltd. (University of Liverpool)

The LONGEVITY project, led by the University of Liverpool, is developing long-acting injectable formulations of drugs for TB prevention, and a cure for hepatitis C. A licence for the products stemming from this project was signed with Tandem Nano Ltd. in September 2021.

GLAD Project — University of Washington

The GLAD project, led by the University of Washington, aims to transform first-line HIV treatment oral combination regimens based on dolutegravir (TLD) into an injectable that would have a lasting effect of one to three months. A licence for the outcome of this project was signed with the University of Washington in December 2021.

→ Access the UoW–MPP licence

IMPACT Project — MedinCell

The IMPACT project, led by MedinCell, is developing a malaria vector control tool that could be delivered sub-cutaneously for three months to adults in high-risk areas, using MedinCell’s BEPO® LA platform to deliver ivermectin and decrease malaria transmission at community level.

→ Access the MedinCell–MPP licence

Long-Acting Biotherapeutics : The Next Frontier

Many of the promising long-acting innovations in the pipeline are biotherapeutics, including monoclonal antibodies (mAbs). These products are critical for both infectious diseases and non-communicable diseases, but present unique access challenges for LMICs due to higher manufacturing complexity, costs and IP barriers.

MPP is actively working at the intersection of long-acting therapeutics and biotherapeutics to ensure that these next-generation products reach those who need them most. Key areas of focus include:

Long-acting monoclonal antibodies for RSV prevention in children: Each year, RSV leads to over 3.6 million hospitalisations and around 100,000 deaths in children under 5, with 97% of paediatric deaths occurring in LMICs. Game-changing long-acting monoclonal antibodies such as nirsevimab and clesrovimab can prevent most of these unnecessary infant deaths. MPP has prioritised RSV mAbs for in-licensing, building on its work on mechanisms to expand access to biologics in LMICs.

Long-acting HIV therapeutics: HIV prevention and treatment pipeline of long-acting options is a rapidly evolving, spanning injectable and oral formulations for less frequent administration intervals than daily. Ensuring timely and equitable access to these innovations in LMICs, where the burden of HIV is greatest, is central to MPP’s work. Beyond injectable PrEP and treatment options, MPP is actively working on long-acting oral candidates for HIV prevention and treatment.

MK-8527 is an investigational once-monthly oral nucleoside reverse transcriptase translocation inhibitor (NRTTI) for HIV pre-exposure prophylaxis (PrEP), in final phases of development. If successful, a once-monthly oral PrEP option could transform HIV prevention delivery, expanding access at a lower cost and offering a user-friendly alternative to both daily pills and injectable regimens.

Long-acting dual oral regimens for HIV treatment are also advancing in the pipeline. A once-weekly oral fixed-dose combination of islatravir and lenacapavir (ISL+LEN), is in Phase III trials, while a once-weekly oral combination of islatravir and ulonivirine (ISL+ULO) is progressing in Phase II/III. These long-acting treatment options could represent a significant step towards less-frequent oral alternatives to daily antiretroviral therapy, with important implications for adherence and decentralised care, provided timely access strategies for LMICs are embedded as early as possible. Moreover, their less complex manufacturing processes could warrant a valuable opportunity for local and regional manufacturing.

Long-acting therapeutics for tuberculosis prevention: A major bottleneck in TB control is the underuse of tuberculosis preventive therapy (TPT), in part due to the length and complexity of current daily oral multi-pill regimens. Long-acting formulations could dramatically shorten TPT and improve completion rates. LA candidates for TPT based on already approved medicines are being investigated by academic groups (LA rifapentine) and by pharmaceutical companies (LA bedaquiline).

Long-acting incretin-based therapies for diabetes, obesity and beyond: GLP-1 receptor agonists (GLP-1 RAs) and related incretin-based therapies represent one of the most significant recent advances in the management of type 2 diabetes, obesity and other indications. Current injectable GLP-1 RAs such as semaglutide and tirzepatide are administered once weekly by subcutaneous injection, while next-generation formulations, injectable and oral, in clinical development aim to extend dosing intervals even further. In September 2025, WHO added representatives of this class to its Essential Medicines List for type 2 diabetes in high-risk populations, and in December 2025 issued its first global guideline recommending GLP-1 therapies for the long-term treatment of obesity in adults.

Yet access to these transformative medicines in LMICs remains severely limited, and MPP is committed to supporting their increased availability and affordability.

Monoclonal antibodies (mAbs) for HIV: Long-acting monoclonal antibodies are being explored for peri- and post-natal HIV prophylaxis and as potential components of future long-acting treatment regimens. In particular, as long-acting ARVs are not currently available in formulations suitable for neonates and infants, a critical gap remains in HIV prevention for this age group. Indeed, despite the availability of effective antiretroviral therapy, an estimated 120,000 children still acquired HIV through vertical transmission in 2024, with approximately half of these infections occurring through breastmilk after birth. Late diagnosis of maternal HIV, challenges in adhering to daily oral ART during pregnancy and the breastfeeding period, as well as HIV acquisition during pregnancy or the postnatal period remain key drivers of vertical transmission, particularly in sub-Saharan Africa. In such context, HIV mAbs could be game-changing to dramatically reduce vertical transmission of HIV and safely cover the breastfeeding period, this way accelerating the elimination of pediatric HIV.

MPP’s expanded mandate to cover biotherapeutics, its work on technology transfer and local and regional manufacturing are essential to making these complex long-acting products accessible and affordable in LMICs.