Drug name
Last update: Oct 2026fremocapavir (VH-499)
Developer(s)
Drug information
Not provided
fremocapavir (VH-499; VH-4011499)
Not provided
Small molecule
Capsid inhibitor — HIV-1 Capsid inhibitor
Active / In Development (Phase 1/2/3)
VH-499 is an investigational drug currently in clinical development for long-acting HIV-1 treatment and pre-exposure prophylaxis. It functions via a multistage mechanism of action inhibiting both early and late HIV-1 replication. VH-499 has shown potent antiviral activity against a broad range of HIV-1 lab strains and clinical isolates at picomolar EC50 levels. Pre-existing resistance to this inhibitor is thought to have a low likelihood. The geometric mean half-life was estimated to have a range 51-66 hours. Interim results of NCT06724640 shows that median time to maximum VH-499 concentration (tmax) was approximately 7 to 18 days post-dose for IM; tmax was approximately 112 days post-dose for SC due to slower absorption. Maximum VH-499 concentrations were lower for SC compared to IM.
Compound is currently in clinical development and not yet approved in any jurisdiction.
Not approved yet.
Therapeutic area(s)
- HIV
- Pre-Exposure Prophylaxis (PrEP)
- Treatment
- Prevention
Administration route
Subcutaneous, Intramuscular, Oral
Associated long-acting platforms
Unknown
Use of drug
- Administered by a community health worker
- Administered by a nurse
- Administered by a specialty health worker
- To be determined
- Every 6 months
- Every 4 months
Dosage
100 1200mg IM or SC
VH-499 1200mg long-acting injection (IM or SC)
VH-4011499 is being studied with doses between 100 mg to 1200mg, administered via subcutaneous (SC) or intramuscular (IM) injection.
The recommended dose and dosing regimen were derived from the interim results of clinical trial NCT06724640, and are subject to changes during the development program.
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. Shionogi joined in October 2012
Shionogi
From 20 January 2026, Shionogi & Co will hold subsidary stake in ViiV healthcare ltd. Shinogi is a drug discovery-based pharmaceutical company to create innovative products and services and to deliver value in collaboration with a diverse array of partners.
Drug structure
Scale-up and manufacturing prospects
Not provided
Not provided
Not provided
Not provided
Excipients & delivery device(s)
Not provided
Not provided
Not provided
Not provided
Safety, Efficacy and Evidence Summary
Not provided
Not provided
Not provided
Not provided
formula Id composition solution, comprising PEG
A pharmaceutical composition comprising the compound of Formula Ia, Formula Ib, Formula Ic, or Formula Id, or a pharmaceutically acceptable salt thereof, is set forth. (Formula Ia), (Formula Ib), (Formula Ic), (Formula Id)
WO2021209900
Formulation
VIIV HEALTHCARE UK
Not provided
April 13, 2041
Pending: AU, BR, CA, CL, CN, EP, IL, JP, KR, MY, MX, RU, ZA, US, VN
VH4011499 compound
The invention relates to compounds, compositions, and methods for the treatment of human immunodeficiency virus (HIV) infection. More particularly, the invention provides novel inhibitors of HIV, pharmaceutical compositions containing such compounds, and methods for using these compounds in the treatment of HIV infection. The invention also relates to methods for making the compounds hereinafter described.
WO2020254985
Compound
VIIV HEALTHCARE UK
Not provided
June 17, 2040
Granted: AU, CN, DZ, EA (AM, AZ, BY, KG, KZ, TJ, TM), EP (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LI, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR, BA, ME, MA, MD), IL, IN, MX, NG, RU, SG, UA, US Pending: AR, BR, CA, CL, CO, CR, DO, EG, GC, HK, ID, JP, KR, MY, NZ, PK, PA, PE, PH, ZA, TW, TH, TT, UY, VE, VN