STI Cure Pipeline 2026 — What Is Actually in Trials
The 2020s have produced the strongest STI cure pipeline in decades. The mRNA platform validated by COVID is being applied to herpes. CRISPR is advancing for both HIV and HSV. Lenacapavir's twice-yearly injection for HIV is reshaping prevention and likely treatment too.
Below: current trials by condition. Each entry includes developer, phase, mechanism, why it matters, and realistic timeline. No hype, no fake hope, just the science.
Three things to keep in mind
- "Cure" has multiple meanings. Therapeutic vaccine (reduces outbreaks). Functional cure (no virus detectable, no treatment needed). Sterilizing cure (every viral copy gone). These are different goals with different timelines.
- Phase 1/2 ≠ available next year. A Phase 2 result is usually 5-8 years from market for a complex therapeutic.
- Most pipeline candidates fail. The history of herpes and HIV vaccines is littered with promising candidates that did not survive Phase 3. Multiple parallel paths de-risk this.
Herpes (HSV) pipeline
mRNA-1608 (HSV-2 therapeutic vaccine) — Moderna
- Phase 1/2
- mRNA encoding HSV-2 surface proteins
- First serious mRNA shot at herpes. Same platform as COVID vaccine.
- Expected early efficacy data late 2026 / early 2027.
BNT163 (HSV-2 therapeutic vaccine) — BioNTech
- Phase 1
- Multivalent mRNA — multiple HSV proteins for broader immune response
- Competing approach alongside Moderna. Two well-funded mRNA shots is the strongest pipeline signal we have ever had.
- Expected 2026 readouts.
Pritelivir (helicase-primase inhibitor) — AiCuris
- Phase 3 completed 2024
- Different antiviral mechanism than acyclovir; active against acyclovir-resistant HSV
- First genuinely new herpes antiviral in decades. FDA approval submission expected. Especially important for immunocompromised patients.
- 2026-2027 likely approval.
EBT-HSV1 (CRISPR gene therapy) — Excision BioTherapeutics
- IND-enabling
- CRISPR-Cas9 via AAV — cuts HSV-1 DNA out of nerve cells
- The "sterilizing cure" approach. Mice studies showed major reduction in latent viral DNA. Years from clinical use.
- Phase 1 anticipated 2026-2027.
GEN-003 — Previously Genocea; rights changed hands
- Phase 2 (paused)
- HSV-2 protein subunit + adjuvant
- Phase 2 data showed real outbreak reduction. Genocea bankruptcy in 2022 paused progress.
- Future uncertain — depends on new sponsor.
HIV pipeline
Lenacapavir for HIV treatment — Gilead
- Phase 3
- Twice-yearly subcutaneous injection
- After being approved for PrEP (twice-yearly prevention), Gilead is pursuing twice-yearly treatment too. Transformational for adherence.
- Phase 3 readouts 2026-2027.
EBT-101 (HIV CRISPR) — Excision BioTherapeutics
- Phase 1/2
- CRISPR-Cas9 to excise HIV proviral DNA
- Most-advanced CRISPR HIV cure program in humans. Early safety/feasibility data ongoing.
- Phase 1 readouts 2025-2026.
A5374 (Immune priming) — NIH-funded
- Phase 2
- Vaccinate first, then start ART — trains immune system to control HIV
- A path to functional cure that does not require gene editing. Targets the natural-immune-control approach.
- Late 2020s readouts.
AGT103-T (HIV gene therapy) — American Gene Technologies
- Phase 1
- CAR-T-like therapy — modifies own T-cells to resist HIV
- Single-dose gene therapy potential. Early-phase but mechanism is unique.
- Early data 2025.
Broadly neutralizing antibodies (multiple)
- Phase 2
- Injectable antibodies that neutralize multiple HIV strains
- Could function as long-acting prevention or treatment adjunct. Most studied platform after ART itself.
- Ongoing readouts.
HPV pipeline
Single-dose Gardasil — WHO research consortium
- Real-world evidence accumulating
- Reduce vaccination schedule from 2-3 doses to 1 dose
- Already endorsed by WHO. US guidelines still recommend 2-3 doses but evidence is shifting.
- US policy shift possible 2026-2028.
VTP-200 (Barinthus Therapeutics)
- Phase 1/2
- Therapeutic HPV vaccine for persistent infection
- First serious therapeutic HPV vaccine candidate. Targets women with persistent high-risk HPV (HPV-16/18).
- 2025-2026 readouts.
AHCC (Active Hexose Correlated Compound)
- Phase 2 (immune support)
- Mushroom-derived immunomodulator
- Several studies suggest accelerated HPV clearance. Evidence still building. Available OTC as a supplement.
- Ongoing community use.
FAQ
When will there be a herpes cure? A "cure" depends on definition. A therapeutic vaccine that meaningfully reduces outbreaks (Moderna, BioNTech) is plausible for late 2020s pending Phase 2/3 success. A sterilizing cure that eliminates the virus entirely (CRISPR approaches) is further out — 2032-2035 at earliest. Pritelivir, a much better antiviral, is at the FDA now.
When will there be an HIV cure? Lenacapavir for treatment (twice-yearly injection) is the nearest game-changer — 2026-2027 likely. Functional cure via gene therapy, CRISPR, or broadly neutralizing antibodies — multiple lines of research in Phase 1/2 trials. Realistic timeline for first approved curative therapy: 2028-2032.
What is the difference between functional and sterilizing cure? Functional cure: virus is suppressed below detectable levels with no ongoing treatment. Carrier is asymptomatic. Sterilizing cure: every copy of viral DNA is removed from the body — patient is biologically virus-free. Sterilizing cure is harder because viruses hide in long-lived cells.
Are clinical trials enrolling participants? Yes — both Moderna (mRNA-1608) and BioNTech (BNT163) are enrolling at multiple US sites. Search ClinicalTrials.gov for "HSV-2" or "HIV cure" to find current studies near you. Most trials are participant-friendly — covering travel, monitoring, and providing medications during the study.
How current is this tracker? Last updated May 2026 based on publicly available trial registrations, conference presentations, and FDA submissions. Trial phases and timelines change frequently — when a specific trial matters to you, check the latest on ClinicalTrials.gov.
For more on each STI individually, see our pillar guides: herpes · HIV · HPV · molluscum · chlamydia · syphilis.
