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Racivir
Racivir is a Small molecule drug developed by Pharmasset. It is currently in Phase 1 development.
Racivir is a small molecule, specifically a nucleoside reverse transcriptase inhibitor (NRTI), used in experimental treatments. It is the enantiomer of emtricitabine, a widely used NRTI, and has been studied in clinical trials for conditions including HIV infection and fatty liver disease.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Racivir |
|---|---|
| Sponsor | Pharmasset |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study) (PHASE2)
- Evaluation of Single Dosing With Two F/TAF Tablets Among Healthy Volunteers (PHASE1)
- The Women TAF-FTC Benchmark Study (PHASE2, PHASE3)
- Safety Of Nrtis for Alzheimer's Therapeutic Advancement in Singapore Study (PHASE1)
- Study to Evaluate the Efficacy and Safety of a Rilpivarine-based Antiretroviral Tratment Regimen in HIV- Infected Patients With Liver Metabolic Disease Who Maintain Udetectable HIV Viral Load (PHASE4)
- Doravirine for Obese Persons on Integrase Inhibitors and Tenofovir Alafenamide (PHASE4)
- Safety, Tolerability and Effectiveness of DTG/3TC vs BIC/TAF/FTC in PWH Without Antiretroviral Experience (PHASE4)
- Utilizing Private Pharmacies to Initiate High-risk Young Individuals on PrEP in South Africa (PHASE4)
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:
- Racivir CI brief — competitive landscape report
- Racivir updates RSS · CI watch RSS
- Pharmasset portfolio CI
Frequently asked questions about Racivir
What is Racivir?
Who makes Racivir?
What development phase is Racivir in?
Related
- Manufacturer: Pharmasset — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing