Drug name
Last update: Aug 2026Cabotegravir + Lenacapavir
Developer(s)
Drug information
Cabotegravir and Lenacapavir
Apretude (CAB), Vocabria (CAB), Sunlenca (LEN)
Small molecule
INSTI+capsid inhibitor
The use of cabotegravir and lenacapavir (CAB/LEN) for HIV treatment is investigated as an asynchronous co-administration of the two separately approved medicines. Currently, the only approved complete long-acting ART therapy regimen is a combination of intramuscular CAB and rilpivirine (CAB/RPV). On the other hand, LEN is approved for the treatment of multidrug-resistant (MDR) HIV in combination with an orally administered background regimen. The co-administration of CAB LA plus LEN (± RPV LA), has not been studied in large multisite randomized, controlled clinical trials. However, multiple case series have reported high rates of viral suppression with use of CAB LA plus LEN, ± RPV, in real-life situations.
Use of CAB LA plus LEN (± RPV LA) is not approved in any jurisdiction.
Use of CAB LA plus LEN (± RPV LA) is not approved in any jurisdiction.
Therapeutic area(s)
- HIV
- Treatment
Administration route
Subcutaneous, Intramuscular, Oral
Associated long-acting platforms
Aqueous drug particle suspension, Aqueous solution, Oral solid form
Use of drug
- Administered by a community health worker
- Administered by a nurse
- Administered by a specialty health worker
- Monthly
- Every 2 months
- Other/Variable/Unknown : To be determined based on clinical data and regulatory approvals
- Every 6 weeks
Dosage
CAB, LEN and RPV are commercially available in various presentations. However CAB/LEN+-RPV is not yet approved for HIV treatment.
Not provided
Co-administration of long-acting cabotegravir (CAB LA) and lenacapavir (LEN), with or without long-acting rilpivirine (± RPV LA) has not been studied in randomized, controlled clinical trials. Use of CAB LA plus LEN (± RPV LA) is not approved in any jurisdiction. Dosing, schedule and specific use would need to be determined and sublited for approval.
Not provided
Not provided
Associated compounds, formulations and regimens
Cabotegravir (CAB)
Lenacapavir (LEN)
Associated technologies
Not provided
Additional information
Developer(s)
ViiV Healthcare
ViiV Healthcare is a pharmaceutical company that specializes in the development of therapies for HIV infection. The company is headquartered in Brentford in the United Kingdom and was initially formed in November 2009 as a part of a joint venture between GlaxoSmithKline and Pfizer.
Gilead
Gilead Sciences, Inc. is a multinational biopharmaceutical company that develops and manufactures innovative medicines for life-threatening diseases, including anti-viral therapeutics for HIV/AIDS, Hepatitis B, Hepatitis C and Covid-19. Headquartered in Foster City, California, Gilead was originally founded in 1987 and is currently listed on both the S&P 500 and the NASDAQ Biotechnology Index.
Drug structure
Scale-up and manufacturing prospects
Cabotegravir is commercially manufactured by the innovator (ViiV Healthcare) and three generic manufacturers have received a licence through the Medicines Patent Pool to manufacture generic versions by 2026/2027. Lenacapavir is commercially manufactured by Gilead Sciences Inc. and 6 generic manufacturers have received a licence through Gilead for manufacturing of LEN.
Cabotegravir: Conventional wet-bead milling (ball mill), depyrogenated glass vials. Lenacapavir: Equipment: Stainless steel pharmaceutical reactors, glass-lined reactors, rotary evaporator (rotovap), flash chromatography columns, stainless steel autoclave, cooling bath, silica gel chromatography columns, vacuum distillation apparatus, simulated moving bed chromatography system, Chiralpak columns.
Cabotegravir is subject to a gamma-irradiation pre-sterilization step prior to a conventional wet-bead milling manufacturing procedure. The Cabotegravir milling process is initiated alongside pharmaceutical excipients (polyethylene glycol 3350, water for injection, polysorbate 20 and mannitol) for an overall 200nm drug particle size. Storage of injectable lenacapavir in borosilicate vials is contraindicated due to issues with chemical compatibility. Instead, it is recommended that vials are made from aluminosilicate glass.
Cabotegravir: PANalytical X’Pert PRO diffractometer equipped with a theta/theta coupled goniometer (or equivalent x-ray powder diffractor) to determine drug particle size, Mettler TGA/DSC 1 instrument for thermal analysis, HPLC to evaluate drug content, impurities and dissolution, HPLC UV-Vis Detector for drug identification. Lenacapavir: Proton nuclear magnetic resonance (1H NMR), High-performance liquid chromatography (HPLC), Ultra-Performance Liquid Chromatography (UPLC).
Excipients & delivery device(s)
No proprietary excipient used
No novel excipient or existing excipient used
No residual solvent used
No delivery device
Safety, Efficacy and Evidence Summary
Not provided
Not provided
Not provided
Not provided