Long-Acting HIV Treatment and Prevention
As of 6 November 2026, Drugnews tracks 15 long-acting HIV assets: 7 approved and 8 in development; 9 for treatment and 6 for prevention.
HIV is now a manageable chronic disease. The hard part is taking pills every day for life. Long-acting drugs aim to change that: from a daily pill to a weekly pill, an injection every two months, or even two shots a year.
This page tracks 15 assets: 7 approved and 8 in development; 9 for treatment and 6 for prevention. Taiwan's TaiMed Biologics has two, and China's albuvirtide is the other Asian entry.
01 | Prevention: twice-yearly shots are on the market, priced for two worlds
- Apretude (cabotegravir): ViiV, approved December 2021, one injection every two months, the first long-acting PrEP.
- Yeztugo (lenacapavir): Gilead, approved 18 June 2025, two shots a year; US list price US$28,218 a year and Q3 2026 sales of US$305 million.
- Generic lenacapavir: on 2 November 2026 Dr. Reddy's received FDA tentative approval to supply 120 low- and middle-income countries at about US$40 a year.
The US price of the same drug is more than 700 times the generic price. Gilead granted royalty-free licenses to six generic makers in 2024. Countries on the list get the cheap drug; the US, Europe, Japan and Taiwan are not on it.
Longer-acting options are next. The FDA is due to decide on once-weekly oral Yeztugo on 2 February 2027, a once-yearly version is in the Phase 3 PURPOSE 365 trial, and MSD's monthly oral alimatravir (MK-8527) has two Phase 3 trials of more than 4,000 people each.
02 | Treatment: who can let stable patients dose every few months
- Trogarzo (ibalizumab): TaiMed, approved 2018, binds the human CD4 receptor, for multidrug-resistant patients.
- Cabenuva: ViiV/Janssen, approved January 2021, monthly or every two months, the first complete long-acting injectable regimen.
- Sunlenca (lenacapavir): Gilead, approved December 2022, twice yearly, for multidrug-resistant patients.
Two routes are in development.
A weekly pill. Gilead and MSD's islatravir plus lenacapavir met non-inferiority at week 48 in both Phase 3 ISLEND trials. Gilead's other weekly oral combination continues in WONDERS-1 (675 people), while WONDERS-2 in treatment-naive people was terminated in March 2026.
Antibodies plus long-acting drugs. Gilead added two broadly neutralizing antibodies to lenacapavir and began two Phase 3 trials of 590 people each in July 2026, one directly against Cabenuva. ViiV's lotivibart every four months with monthly cabotegravir achieved viral suppression in 94% (IV) and 82% (subcutaneous) of patients in Phase 2b, versus 88% on continued oral therapy.
The shared weakness of the antibody route is viral variation. Antibodies aimed at the viral envelope only work on sensitive virus; in Gilead's early screening, only 44% of 124 people had virus sensitive to both antibodies.
03 | Taiwan: where TaiMed stands
TaiMed's TMB-365 binds domain 2 of the human CD4 receptor and TMB-380 targets the viral envelope. Used together, one guards the door and the other chases the virus.
- Phase 2a: 20 patients dosed every 8 weeks had no virologic failure through 24 weeks.
- IDWeek 2026: TMB-365 still blocked 19 of 20 viruses with reduced sensitivity to TMB-380.
- Phase 2b: fully enrolled at 88 patients, with a control group on continued oral therapy; interim results by end-2026 and primary analysis in May 2027.
- The company says it is in licensing and partnership talks with several global drugmakers and the US NIH.
Of the 9 treatment assets on this page, TMB-365/TMB-380 is the only all-antibody combination with no small molecule. It has two questions to answer: whether viral suppression matches oral therapy, and whether dosing can move from IV every 8 weeks to longer intervals or subcutaneous injection.
04 | Timeline
- End of 2026: TaiMed TMB-365/TMB-380 Phase 2b interim results.
- 2 February 2027: FDA decision date for once-weekly oral Yeztugo.
- 2027: primary completion of MSD's two alimatravir Phase 3 trials.
- Ongoing: Gilead's two Phase 3 trials of lenacapavir plus two antibodies, and the Phase 3 of once-yearly lenacapavir.
Stage distribution
Country distribution
Treatment
| Drug | Company | Country | Mechanism | Route | Dosing interval | Stage | Indication | Trial ID | Deal | Latest development and date | Sources |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Trogarzo (ibalizumab) | TaiMed Biologics (TPEx: 4147) | Taiwan | Monoclonal antibody that binds the human CD4 receptor so the virus cannot enter cells | Intravenous injection | Every 2 weeks | Approved | Heavily treatment-experienced adults with multidrug-resistant HIV | — | — | FDA-approved on 2018-03-06, the first monoclonal antibody approved for HIV | cm.healio.com |
| Albuvirtide (Aikening) | Frontier Biotechnologies | China | Long-acting HIV-1 fusion inhibitor | Intravenous injection | Weekly | Approved (China) | Treatment-experienced HIV-1 (with other antiretrovirals) | NCT02369965 | — | Approved in China in May 2018 | clinicaltrials.gov drugnews.com.tw |
| Cabenuva (cabotegravir + rilpivirine) | ViiV Healthcare / Janssen | UK / US | Integrase inhibitor plus NNRTI, long-acting injection | Intramuscular injection | Monthly or every 2 months | Approved | Virologically suppressed adults | — | — | FDA-approved on 2021-01-21, the first complete long-acting injectable regimen | www.jnj.com |
| Sunlenca (lenacapavir) | Gilead Sciences | US | Capsid inhibitor | Subcutaneous injection | Every 6 months | Approved | Multidrug-resistant HIV in adults (with other drugs) | — | — | FDA-approved on 2022-12-22, the first twice-yearly HIV treatment | www.gilead.com |
| Islatravir + lenacapavir (weekly oral) | Gilead / MSD | US | NRTTI plus capsid inhibitor | Oral | Weekly | Phase 3 completed | Virologically suppressed adults | NCT06630286 NCT06630299 | — | ISLEND-1 (607, vs Biktarvy) and ISLEND-2 (626) met non-inferiority at week 48; presented at AIDS 2026 in July and published in NEJM | www.healio.com clinicaltrials.gov |
| Lenacapavir + teropavimab + zinlirvimab | Gilead Sciences | US | Capsid inhibitor plus two broadly neutralizing antibodies targeting the viral envelope | Injection | Every 6 months (target) | Phase 3 | Virologically suppressed adults (antibody-sensitive virus) | NCT07683000 NCT07682961 | — | Two Phase 3 DAYBREAK trials of 590 each began enrolling in July 2026, one against Cabenuva; in earlier screening only 44% of 124 people had virus sensitive to both antibodies | clinicaltrials.gov clinicaltrials.gov www.aidsmap.com |
| Lepetegravir + lenacapavir pacfosacil (weekly oral) | Gilead Sciences | US | Integrase inhibitor plus capsid inhibitor prodrug | Oral | Weekly | Phase 2/3 | Virologically suppressed adults | NCT06544733 NCT06613685 | — | WONDERS-1 (675) ongoing; WONDERS-2 in treatment-naive people terminated by the sponsor in March 2026 | clinicaltrials.gov clinicaltrials.gov |
| Lotivibart (N6LS) + cabotegravir | ViiV Healthcare | UK | Broadly neutralizing antibody (every 4 months) plus monthly cabotegravir | Intravenous or subcutaneous + intramuscular injection | Antibody every 4 months | Phase 2b | Virologically suppressed adults | — | — | EMBRACE at 12 months: viral suppression 94% (IV), 82% (subcutaneous) vs 88% for continued oral therapy | viivhealthcare.com |
| TMB-365 / TMB-380 | TaiMed Biologics (TPEx: 4147) | Taiwan | Dual antibodies: TMB-365 binds domain 2 of the human CD4 receptor; TMB-380 targets the viral envelope's CD4-binding site | Intravenous injection | Every 8 weeks | Phase 2b | Virologically suppressed adults (maintenance) | NCT07215468 NCT05275998 NCT04027387 | The company says it is in licensing and partnership talks with several global drugmakers and the US NIH | Phase 2b fully enrolled at 88 (vs continued oral therapy), interim results by end-2026 and primary analysis May 2027; IDWeek 2026: TMB-365 still blocked 19 of 20 viruses with reduced TMB-380 sensitivity; Phase 2a in 20 patients dosed every 8 weeks had no virologic failure through 24 weeks | clinicaltrials.gov www.globenewswire.com news.cnyes.com www.biospace.com |
Prevention (PrEP)
| Drug | Company | Country | Mechanism | Route | Dosing interval | Stage | Indication | Trial ID | Deal | Latest development and date | Sources |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Apretude (cabotegravir) | ViiV Healthcare | UK | Integrase inhibitor, long-acting injection | Intramuscular injection | Every 2 months | Approved | Pre-exposure prophylaxis (PrEP) | — | — | FDA-approved on 2021-12-20, the first long-acting injectable PrEP | viivhealthcare.com |
| Yeztugo (lenacapavir) | Gilead Sciences | US | Capsid inhibitor | Subcutaneous injection | Every 6 months | Approved | Pre-exposure prophylaxis (PrEP) | — | — | FDA-approved on 2025-06-18; US list price US$28,218 a year; Q3 2026 sales US$305M | www.contagionlive.com www.drugs.com investors.gilead.com |
| Generic lenacapavir | Dr. Reddy's (Gilead voluntary license) | India | Capsid inhibitor | Subcutaneous injection | Every 6 months | Tentative approval (generic) | PrEP in 120 low- and middle-income countries | — | Oct 2024 royalty-free voluntary licenses to six generic makers; Sept 2025 price of about US$40 a year agreed with Unitaid, CHAI and Wits RHI | FDA tentative approval on 2026-11-02 (not sold in the US, eligible for US aid purchasing); first supplies by end of 2026 | www.contagionlive.com |
| Weekly oral Yeztugo (lenacapavir) | Gilead Sciences | US | Capsid inhibitor | Oral | Weekly | Under FDA review | PrEP | — | — | FDA accepted the application on 2026-06-15; decision date 2027-02-02 | www.gilead.com |
| Alimatravir (MK-8527) | MSD | US | NRTTI | Oral | Monthly | Phase 3 | PrEP | NCT07044297 NCT07071623 | — | Two Phase 3 trials (4,390 and 4,580), primary completion in 2027 | clinicaltrials.gov clinicaltrials.gov |
| Once-yearly lenacapavir | Gilead Sciences | US | Capsid inhibitor | Injection | Once a year | Phase 3 | PrEP | — | Voluntary licensing already extended to the once-yearly version | Phase 3 PURPOSE 365 ongoing; global access planning accelerated in Sept 2026 | investors.gilead.com |
Frequently asked questions
Which long-acting HIV drugs are approved?
Trogarzo (ibalizumab) — Approved; Cabenuva (cabotegravir + rilpivirine) — Approved; Sunlenca (lenacapavir) — Approved; Albuvirtide (Aikening) — Approved (China); Apretude (cabotegravir) — Approved; Yeztugo (lenacapavir) — Approved; Generic lenacapavir — Tentative approval (generic). FDA tentative approval on 2026-11-02 (not sold in the US, eligible for US aid purchasing); first supplies by end of 2026
Why does lenacapavir cost about US$40 a year in low- and middle-income countries?
Oct 2024 royalty-free voluntary licenses to six generic makers; Sept 2025 price of about US$40 a year agreed with Unitaid, CHAI and Wits RHI. FDA tentative approval on 2026-11-02 (not sold in the US, eligible for US aid purchasing); first supplies by end of 2026
How far have TaiMed’s TMB-365 / TMB-380 progressed?
Phase 2b fully enrolled at 88 (vs continued oral therapy), interim results by end-2026 and primary analysis May 2027; IDWeek 2026: TMB-365 still blocked 19 of 20 viruses with reduced TMB-380 sensitivity; Phase 2a in 20 patients dosed every 8 weeks had no virologic failure through 24 weeks. The company says it is in licensing and partnership talks with several global drugmakers and the US NIH