Drug name
Last update: Oct 2026VH-184 + VH-499
Developer(s)
Drug information
Not provided
VH-184 and VH-499 (fremocapavir)
investigational
Small molecule
3rd gen. integrase strand transfer inhibitor (INSTI) + capsid inhibitor (CI)
Investigational, potentially twice-yearly, complete long-acting injectable regimen pairing ViiV Healthcare's third-generation INSTI VH-184 with its capsid inhibitor VH-499 (fremocapavir). Both agents are being developed individually as injectables; ViiV describes VH-184 and VH-499 as potential components of future ultra long-acting treatment regimens, and states that the phase I data will inform its plans for a first INSTI-based twice-yearly regimen, without specifying the partner drug (ViiV press release, 25 Feb 2026). The pairing of the two agents as a single regimen is reported by TAG (Pipeline Report 2026). In phase I studies in adults without HIV, a single injection of VH-184 (formulation B) maintained flat plasma concentrations through month 7, and single IM or SC injections of VH-499 (100 to 1,200 mg) maintained stable concentrations supporting dosing intervals of up to six months. VH-184 retains activity against HIV with second-generation INSTI resistance substitutions in vitro, and VH-499 binds the CPSF6/nucleoporin pocket of the capsid with picomolar potency. No clinical trial co-administering the two agents had been registered a
Investigational. Not approved in any jurisdiction. The combination has not yet entered clinical testing as a regimen; each component is in clinical development (VH-184: oral phase IIb INNOVATE, injectable phase I; VH-499: oral phase IIa CINNAMON completed, injectable phase I, phase IIb CINERGY with cabotegravir not yet recruiting) (last updated 30 September 2026)
Not applicable (no regulatory submission).
Therapeutic area(s)
- HIV
- Treatment
Administration route
Subcutaneous, Intramuscular
Associated long-acting platforms
not disclosed
Use of drug
- Administered by a nurse
- Administered by a specialty health worker
- Every 6 months
Dosage
Not established for the regimen. VH-499: single IM or SC doses of 100 to 1,200 mg studied in phase I. VH-184: LA formulations A and B (and C, SC) under evaluation
VH-499: 1,200 mg single injection (phase I). VH-184: not publicly reported.
Not provided
Twice-yearly target based on population PK simulations (VH-184 formulation B, Q6M) and flat PK after single VH-499 injections. Dosing will be defined in phase IIb.
Not provided
Additional information
Developer(s)
ViiV Healthcare
Shionogi
Drug structure
Scale-up and manufacturing prospects
Not publicly available.
Not publicly available.
Not publicly available.
Not publicly available.
Excipients & delivery device(s)
Not provided
Not provided
Not provided
Not provided
Safety, Efficacy and Evidence Summary
Component data only. VH-184 LA (phase I, 39 participants, formulations A and B, SC or IM): injection site reactions mostly grade 1 (erythema, pain, nodules), fewer grade 2, two grade 3 ISRs; safety profile described as similar to marketed INSTIs. VH-499 LA (phase I, 48 participants at 100/200/400 mg IM or SC): AEs mostly grade 1 to 2, injection site pain in 27/36 (75%) VH-499 recipients, ISRs more frequent after SC (83 to 100%) than IM (33 to 83%), median ISR duration 1 to 3 days, no serious AEs, no withdrawals for safety.
No efficacy data for the combination. Component proof of concept: oral VH-184 monotherapy (phase IIa, ART-naive adults, 10/50/300 mg) produced dose-dependent viral load declines, maximum -2.69 log10 copies/mL at 300 mg; oral VH-499 monotherapy (phase IIa CINNAMON) showed potent antiviral activity over 10 days.
Not provided
Not provided
There are either no relevant patents or these were not yet submitted to LAPaL