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Remune
Remune is a Small molecule drug developed by University of Rochester. It is currently in Phase 2 development. Also known as: HIV-1 Immunogen.
Remune is a therapeutic HIV vaccine based on the killed whole virus approach, initially invented by Jonas Salk in 1987. It was developed by Immune Response BioPharma, Inc. (IRBP) and studied in a clinical trial (NCT00000943) for HIV infections.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
University of Rochester is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Remune |
|---|---|
| Also known as | HIV-1 Immunogen |
| Sponsor | University of Rochester |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Evaluating the Combined Intervention of Nutritional Supplementation (Remune) and Exercise in Patients With Cancer Cachexia (PHASE1)
- Effectiveness of Giving an HIV Vaccine (Remune) to HIV-Positive Patients Receiving an Anti-HIV Drug Combination (PHASE3)
- Immune Responses in HIV-Positive Patients Receiving an Anti-HIV Drug Combination When Given the HIV Vaccines Remune and vCP1452 (PHASE1)
- A Study to Test If Giving Remune (an HIV Vaccine) Can Improve the Immune Systems of HIV-Positive Patients Who Are Also Participating in ACTG 328 (NA)
- Combination Vaccination Before HIV Treatment Interruption (PHASE1, PHASE2)
- REMUNE HIV/AIDS Vaccine Phase II Pediatric Safety & Efficacy Clinical Study (PHASE2)
- REMUNE + AMPLIVAX IR103 HIV/AIDS Phase III Safety & Efficacy Study (PHASE3)
- Effectiveness of Adding Remune to Your Current Anti-HIV Drug Combination (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:
- Remune CI brief — competitive landscape report
- Remune updates RSS · CI watch RSS
- University of Rochester portfolio CI
Frequently asked questions about Remune
What is Remune?
Who makes Remune?
Is Remune also known as anything else?
What development phase is Remune in?
Related
- Manufacturer: University of Rochester — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: HIV-1 Immunogen
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing