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Tenofovir Douche
Tenofovir Douche is a Small molecule drug developed by Johns Hopkins University. It is currently in Phase 1 development. Also known as: TFV 660 mg in hypo-osmolar solution.
Tenofovir is a small molecule that inhibits human immunodeficiency virus type 1 reverse transcriptase. It has been studied as a rectal douche in clinical trials, such as HPTN 106, for HIV prevention.
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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 | Tenofovir Douche |
|---|---|
| Also known as | TFV 660 mg in hypo-osmolar solution |
| Sponsor | Johns Hopkins University |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
- Type I Diabetes
- Nausea
- Polyp
Key clinical trials
- CROSSOVER STUDY OF ON-DEMAND PREP FORMULATIONS COMPARING RECTAL AND ORAL TENOFOVIR (PHASE2)
- Tenofovir Rectal Douche to Prevent HIV Transmission Among Adolescents (ATN DREAM) (PHASE1)
- Evaluating Distribution of a Tenofovir Douche With Tap Water Douching and Simulated Receptive Anal Intercourse (PHASE1)
- Tenofovir Rectal Douche to Prevent HIV Transmission (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:
- Tenofovir Douche CI brief — competitive landscape report
- Tenofovir Douche updates RSS · CI watch RSS
- Johns Hopkins University portfolio CI
Frequently asked questions about Tenofovir Douche
What is Tenofovir Douche?
Who makes Tenofovir Douche?
Is Tenofovir Douche also known as anything else?
What development phase is Tenofovir Douche in?
What are the side effects of Tenofovir Douche?
Related
- Manufacturer: Johns Hopkins University — full pipeline
- Also known as: TFV 660 mg in hypo-osmolar solution
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing