Drug name
Last update: Oct 2026Cabotegravir + Rilpivirine 3 times a year (CAB4M + RPV4M)
Developer(s)
Drug information
Not provided
Cabotegravir ultra long-acting formulation, CAB4M, CAB ULA, CAB 3 times a year) + rilpivirine ultra long-acting formulation, RPV4M, RPV ULA, RPV 3 times a year)
Not applicable (investigational; no brand name assigned)
Small molecule
INSTI (cabotegravir) + NNRTI (rilpivirine)
Investigational complete long-acting injectable regimen designed to extend the dosing interval of cabotegravir plus rilpivirine from every one or two months (approved CAB LA + RPV LA) to every four months, that is three administrations per year. CAB ULA is a higher-concentration cabotegravir formulation with at least double the half-life of the approved 200 mg/mL product; RPV ULA is a new rilpivirine formulation from Johnson & Johnson for which no clinical data have been disclosed. The combination is being evaluated against CAB LA + RPV LA in a phase III registrational study (NCT07650916) in virologically suppressed adults and adolescents.
Investigational. Not approved in any jurisdiction. The approved Q1M and Q2M regimens (Cabenuva; Vocabria + Rekambys) use different formulations.
Not applicable (no regulatory submission yet).
Therapeutic area(s)
- HIV
- Treatment
Administration route
Intramuscular
Associated long-acting platforms
Aqueous drug particle suspension
Use of drug
- Administered by a community health worker
- Administered by a nurse
- Administered by a specialty health worker
- Every 4 months
Not available yet.
Dosage
Treatment doses not publicly disclosed. CAB ULA 1,600 mg/3 mL IM is the dose used in the PrEP registration study EXTEND 4M. RPV4M dose not disclosed.
Not disclosed.
Not established.
Four-monthly IM co-administration of CAB4M and RPV4M
Not provided
Related entries
Cabotegravir (CAB)
Rilpivirine (RPV)
CAB 6 times a year (CAB-LA; Cabotegravir 2-monthly)
Cabotegravir + Lenacapavir
Cabotegravir + Rilpivirine
Cabotegravir 3 times a year (CAB 4M)
cabotegravir PH20
Rilpivirine 2-monthly
Rilpivirine Prodrug Nanoformulation (NM3RPV)
Additional information
Developer(s)
ViiV Healthcare
J&J
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
No delivery device
Safety, Efficacy and Evidence Summary
CAB ULA (phase I, healthy adults, CROI 2024): favourable tolerability and safety; IM better tolerated than SC. RPV ULA: no public safety data identified as of 1 October 2026.
No efficacy data for the ULA combination yet. Phase III NCT07650916 began recruiting in June 2026 (primary completion estimated September 2029).
Not provided
Not provided
There are either no relevant patents or these were not yet submitted to LAPaL