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HIV prevention package including PrEP
HIV prevention package including PrEP is a Small molecule drug developed by ANRS, Emerging Infectious Diseases. It is currently in Phase 1 development.
PrEP is a pre-exposure prophylaxis intervention used to prevent HIV infections. It is a part of a comprehensive HIV prevention package that may also include other interventions, such as the CHAMPION package, which aims to address multiple risk factors for HIV transmission.
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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 | HIV prevention package including PrEP |
|---|---|
| Sponsor | ANRS, Emerging Infectious Diseases |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Improving HIV Prevention Among Heterosexual Men Seeking STI Services in Malawi (NA)
- CHAMPION: Combining HIV And Meth Prevention and Treatment Interventions Optimized for HIV-Negative MSM (NA)
- Naltrexone for Overdose Prevention (PHASE2, PHASE3)
- The Test-to-PrEP Study (NA)
- Testing Implementation Strategies to Improve Delivery of PrEP for Pregnant and Postpartum Women in Kenya (NA)
- Evaluating the Pharmacokinetics, Feasibility, Acceptability, and Safety of Oral Pre-Exposure Prophylaxis for HIV Prevention During Pregnancy and Postpartum (PHASE2)
- SEARCH SAPPHIRE Phase A: A Multisectoral Strategy to Address Persistent Drivers of the HIV Epidemic in East Africa (NA)
- Improving Health Outcomes in Young Cisgender Men and Transgender Women (mLab App) (NA)
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:
- HIV prevention package including PrEP CI brief — competitive landscape report
- HIV prevention package including PrEP updates RSS · CI watch RSS
- ANRS, Emerging Infectious Diseases portfolio CI
Frequently asked questions about HIV prevention package including PrEP
What is HIV prevention package including PrEP?
Who makes HIV prevention package including PrEP?
What development phase is HIV prevention package including PrEP in?
Related
- Manufacturer: ANRS, Emerging Infectious Diseases — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing