LEAP—the Long-Acting/Extended-Release Antiretroviral Research Resource Program 2025-2030

LEAP, established in 2015, is a unique and pioneering program dedicated to accelerating the development of long-acting and extended-release drug formulations for HIV and related infections.

As a National Institute of Health (NIH) R24 research resource program, LEAP plays a distinctive role in the global health landscape by providing free, expert scientific support to advance LA and extended-release therapies for HIV, tuberculosis, and viral hepatitis.

Project overview

The LEAP was established to accelerate the development of long-acting drug formulations by providing specialized scientific support through its core services. LEAP operates through three primary service cores: 

1. Modelling and simulation core
   Providing advanced predictive pharmacometric models such as physiologically-based pharmacokinetic models through open-source platforms, population pharmacokinetic and pharmacokinetic/pharmacodynamic approaches, enabling predictive extrapolation from in vitro and animal data to human contexts and supporting both preclinical and clinical development
2. Translation acceleration programme
   Providing expert consultation to help investigators overcome key development bottlenecks and advance promising long-acting technologies toward clinical evaluation
3. User preferences core
   Develop best practice guidelines and protocols for conducting preference surveys specific to long-acting products, ensuring methodological rigor, and addressing potential biases in data collection and analysis through community engagement activities. 

LEAP’s Communications Core maintains a centralized, continuously updated repository,  LAPaL, of pharmacological information on long-acting therapeutics. It also manages all LEAP web resources, including www.leapresources.org, and promotes LEAP across its digital platforms. In collaboration with Unitaid, Medicines Patent Pool and CELT Global Health, LEAP has continued to develop and support LAPaL, adding new features to improve user experience, enable more tailored searches, and enhance the interactive maps. 

CELT Global Health's objectives

LEAP’s mission focuses on accelerating long-acting drug development via mathematical modelling and equitable access support. LEAP also focuses to drive awareness, understanding, development, and equitable implementation of long-acting therapeutics for unmet global health needs.

CELT Global Healths involvement and goals within LEAP are:

• Work within both the modelling and simulation core and the communications core of the LEAP
• Our mathematical modellers work closely with external stakeholders to provide an efficient modelling service for any specific project requests. Alongside this, we work on improving existing physiologically-based pharmacokinetic and population platforms, and identifying and addressing knowledge gaps where necessary
• As part of the communication’s core, we manage LEAP’s web resources to ensure that the LEAP’s core services are visible and accessible to innovators and drug developers. We work closely with LEAP stakeholders and web developers to continuously enhance the LEAP website, improving usability and information flow. Further, we curate and validate pharmacological data on LA formulations, compounds and technologies for publication on the LAPaL platform, helping maintain a reliable and up to date resource.

Awarding body

Related publications

LEAP has produced 15 peer-reviewed publications since 2015, including modelling papers, review articles, and acceptability surveys.

• The promises and prospects of long-acting therapeutics for treatment and prevention of infectious diseases
• Accelerating generic long-acting antiretrovirals for global HIV treatment: Workshop findings and a roadmap to access
• Investigations of long-acting formulations in children, adolescents, and pregnant women: A systematic review
• A novel formulation enabled transformation of 3 HIV drugs tenofovir-lamivudine-dolutegravir (TLD) from short-acting to long-acting all-in-one injectable
• Predicted effects of the introduction of long-acting injectable cabotegravir pre-exposure prophylaxis in sub-Saharan Africa: A modelling study
• Antiviral supramolecular polymeric hydrogels by self-assembly of tenofovir-bearing peptide amphiphiles
• A holistic review of the preclinical landscape for long-acting anti-infective drugs using HIV as a paradigm
• What clinicians need to know about the development of long-acting formulations
• Need for a standardized translational drug development platform: Lessons learned from the repurposing of drugs for COVID-19
• The future of long-acting agents for preexposure prophylaxis
• Supramolecular nanomedicines through rational design of self-assembling prodrugs