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PRO 2000/5 Gel
PRO 2000/5 Gel is a microbicide Small molecule drug developed by National Institute of Allergy and Infectious Diseases (NIAID). It is currently in Phase 3 development for Prevention of HIV-1 transmission during sexual intercourse.
PRO 2000/5 Gel is a microbicide that prevents HIV-1 transmission by inhibiting viral entry into host cells.
PRO 2000/5 Gel is a vaginal gel that has been studied for its potential to prevent HIV infections, gonorrhea, chlamydial infections, and genital herpes. It was evaluated in a clinical trial (NCT00262106) as a treatment to prevent vaginally acquired HIV infection.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Anti-infectives pathway favourability
+2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | PRO 2000/5 Gel |
|---|---|
| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
| Drug class | microbicide |
| Target | gp120 |
| Modality | Small molecule |
| Therapeutic area | Infectious Diseases |
| Phase | Phase 3 |
Mechanism of action
PRO 2000/5 Gel contains a sulfonated polysaccharide that binds to the HIV-1 envelope glycoprotein gp120, preventing it from interacting with the host cell receptor CD4 and thus inhibiting viral entry. This mechanism of action is thought to be effective in preventing HIV-1 transmission during sexual intercourse.
Approved indications
- Prevention of HIV-1 transmission during sexual intercourse
Common side effects
- Local irritation
Key clinical trials
- BufferGel and PRO 2000/5: Vaginal Gels to Prevent HIV Infection in Women (PHASE2)
- Effects of BufferGel and PRO 2000/5 Gel in Men (PHASE1)
- Trial to Evaluate PRO 2000/5 Gels for the Prevention of Vaginally Acquired HIV Infection (PHASE3)
- Safety and Acceptability of PRO 2000 Vaginal Gel in HIV Uninfected Women in India (PHASE1)
- Safety and Tolerability of the Vaginal Gel PRO 2000/5 (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- PRO 2000/5 Gel CI brief — competitive landscape report
- PRO 2000/5 Gel updates RSS · CI watch RSS
- National Institute of Allergy and Infectious Diseases (NIAID) portfolio CI
Frequently asked questions about PRO 2000/5 Gel
What is PRO 2000/5 Gel?
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Related
- Drug class: All microbicide drugs
- Target: All drugs targeting gp120
- Manufacturer: National Institute of Allergy and Infectious Diseases (NIAID) — full pipeline
- Therapeutic area: All drugs in Infectious Diseases
- Indication: Drugs for Prevention of HIV-1 transmission during sexual intercourse
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing