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Drug

Tenofovir alafenamide fumarate

Approved medicine
ResearchOngoing clinical research
Also known as Biktarvy, Descovy, Genvoya, Odefsey+3 more

Biktarvy, Descovy, Genvoya, Odefsey, Symtuza, Vemlidy, tenofovir alafenamide (as fumarate).

RxNorm1721604
3
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Randomized, Double-blind, Placebo-controlled Phase Ib/IIa Clinical Trial to Evaluate the Efficacy and Safety of TQA3605 Tablets Monotherapy or in Combination With Nucleoside (Acid) Analogues in Treatment-naïve Patients and Treated Patients With Chronic Hepatitis B

Clinical trial2025-12-31Primary completion · ClinicalTrials.gov

Tenofovir Alafenamide for Treatment of Symptoms and Neuroprotection in Relapsing Remitting Multiple Sclerosis

Clinical trial2025-02-14Withdrawn · ClinicalTrials.gov

Study on Therapeutic Effects and Safety of Nucleoside (Acid) Analogues Treatment in Patients With Chronic Hepatitis B With Normal Alanine Aminotransferase and Positive Hepatitis B Virus DNA: a Randomized Controlled Trial

Clinical trial2024-06-01Primary completion · ClinicalTrials.gov

Safety and Efficacy of Tenofovir Alafenamide to Prevent Perinatal Transmission of Hepatitis B (TAF-PPT): A Multicentre, Prospective, Open-label, Randomized Controlled Trial

Clinical trial2022-12-31Primary completion · ClinicalTrials.gov

TAF (Tenofovir Alafenamide) for Preventing Progression of Liver Disease in Non-cirrhotic Chronic HBV Infection With Normal ALT and Low Viral Load - a Randomized Controlled Trial

Clinical trial2022-02-28Results expected Q4 2027 · ClinicalTrials.gov

The Efficacy and Safety of Tenofovir Alafenamide Fumarate Compared With Other Nucleoside Analogues (Acid) to Treat Patients With Low-level Viremia of HBV

Clinical trial2021-10-31Primary completion · ClinicalTrials.gov

A Phase 2, Exploratory Study Evaluating the Safety and Antiviral Efficacy of Inarigivir Soproxil in Non-cirrhotic Treatment-Naive Subjects Infected With Chronic Hepatitis B Virus

Clinical trial2020-04-02Terminated · ClinicalTrials.gov

Analysis of Proximal Renal Tubular Function of "Real World" Chronic Hepatitis B (CHB) Patients Who Are Suppressed on TDF and Switched to TAF

Clinical trial2017-06-21Primary completion · ClinicalTrials.gov

Marketing authorisation: Vemlidy (EMA)

Regulatory2017-01-09EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Tenofovir alafenamide fumarate
Aliases & brands
BiktarvyDescovyGenvoyaOdefseySymtuzaVemlidytenofovir alafenamide (as fumarate)
RxNorm CUI
1721604
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2017-01-09
Latest approval
2017-01-09
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2017-01-09Original application approval
Marketing authorisation: Vemlidy (EMA)

Indication: Vemlidy is indicated for the treatment of chronic hepatitis B (CHB) in adults and paediatric patients 6 years of age and older weighing at least 25 kg (see section 5.1).

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

8 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
8
registered trials across all phases
3
Active studies
2
Recruiting
5
Late-stage (III+)
5
Discontinued
PHASE DISTRIBUTIONn = 8
Phase 1 / 21Phase 22Phase 42Phase N / A3

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Safety and Efficacy of Tenofovir Alafenamide to Prevent Perinatal Transmission of Hepatitis B (TAF-PPT): A Multicentre, Prospective, Open-label, Randomized Controlled Trial

Unknown statusPH IVThe First Affiliated Hospital of Zhengzhou Universityn=2402022

Analysis of Proximal Renal Tubular Function of "Real World" Chronic Hepatitis B (CHB) Patients Who Are Suppressed on TDF and Switched to TAF

Unknown statusPH IVAsian Pacific Liver Center at Coalition of Inclusive Medicinen=822017
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.