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Drug

Emtricitabine

Established medicine
ClassHuman immunodeficiency virus type 1 reverse transcriptase inhibitorResearchOngoing clinical research
Also known as (-)-FTC, Atripla, Biktarvy, Complera+17 more

(-)-FTC, Atripla, Biktarvy, Complera, Descovy, Emtriva, FTC, Genvoya, Odefsey, Stribild, Symtuza, Truvada, Emtricitabin, Emtricitabina, (+/-)-Emtricitabine, (-)-cis-4-amino-5-fluoro-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)-pyrimidin-2-one, (2R-cis)-4-amino-5-fluoro-1-(2-(hydroxymethyl)-1,3-oxathiolan-5-yl)-2(1H)-pyrimidinone, 4-amino-5-fluoro-1-((2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl)pyrimidin-2(1H)-one, 5-fluoro-1-((2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl)cytosine, Emtricitabine, (+/-)-, Emtricitabinum.

3
Active clinical trials
Reverse transcriptase/RNaseH
Primary target
4
Regulatory events
Latest activity
beta

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

Repurposing Nucleoside Reverse Transcriptase Inhibitors for Treatment of AD

Clinical trial2026-03-31Primary completion · ClinicalTrials.gov

Approval: Emtriva (EMA)

Regulatory2003-10-24EMA

Profile

Identifiers & mechanism

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

Canonical name
Emtricitabine
Aliases & brands
(-)-FTCAtriplaBiktarvyCompleraDescovyEmtrivaFTCGenvoyaOdefseyStribildSymtuzaTruvadaEmtricitabinEmtricitabina(+/-)-Emtricitabine(-)-cis-4-amino-5-fluoro-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)-pyrimidin-2-one(2R-cis)-4-amino-5-fluoro-1-(2-(hydroxymethyl)-1,3-oxathiolan-5-yl)-2(1H)-pyrimidinone4-amino-5-fluoro-1-((2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl)pyrimidin-2(1H)-one5-fluoro-1-((2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl)cytosineEmtricitabine, (+/-)-Emtricitabinum
RxNorm CUI
276237
ChEMBL ID
CHEMBL885
ATC codes
J05AF09
UNII
G70B4ETF4S
Primary mechanism
Human immunodeficiency virus type 1 reverse transcriptase inhibitor
Regulatory jurisdictions
fdaema

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

INHIBITORHuman immunodeficiency virus type 1 reverse transcriptase inhibitor

Regulatory timeline

4 events

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
2003-10-24
Latest approval
2021-01-13
Authorities
FDA · EMA
Total events
4
fdaU.S. Food and Drug Administration· 3 events
2024-11-14Label change
Label change: EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (ANDA091055)
Evidence ↗
2024-11-14Label change
Label change: EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (ANDA091055)
Evidence ↗
2021-01-13Approval
Approval: EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (ANDA091055)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2003-10-24Approval
Approval: Emtriva (EMA)
Indication: Emtriva is indicated for the treatment of HIV-1 infected adults and children in combination with other antiretroviral agents. This indication is based on studies inShow full indication

Emtriva is indicated for the treatment of HIV-1 infected adults and children in combination with other antiretroviral agents. This indication is based on studies in treatment-naive patients and treatment-experienced patients with stable virological control. There is no experience of the use of Emtriva in patients who are failing their current regimen or who have failed multiple regimens. When deciding on a new regimen for patients who have failed an antiretroviral regimen, careful consideration should be given to the patterns of mutations associated with different medicinal products and the treatment history of the individual patient. Where available, resistance testing may be appropriate.

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

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

Clinical trials

51 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
51
registered trials across all phases
LATEST COMPLETION 2024
3
Active studies
2
Recruiting
26
Late-stage (III+)
39
Completed
9
Discontinued
PHASE DISTRIBUTIONn = 51
Phase 18Phase 1 / 22Phase 215Phase 311Phase 412Phase N / A3

Late-stage studies

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

CompletedPH IVKirby Instituten=1552024
Unknown statusPH IVKey trialAsian-Pacific Alliance of Liver Disease, Beijingn=2,0002017
Unknown statusPH IVAsian-Pacific Alliance of Liver Disease, Beijingn=2002017
Unknown statusPH IVAsian-Pacific Alliance of Liver Disease, Beijingn=2002016

Recent completions

Trials that read out recently, adding to the completed evidence base.

References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.