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Emtricitabine (FTC)
Emtricitabine (FTC) is a Nucleoside reverse transcriptase inhibitor (NRTI) Small molecule drug developed by National University Hospital, Singapore. It is currently in Phase 3 development for HIV-1 infection (as part of combination antiretroviral therapy), HIV-1 pre-exposure prophylaxis (PrEP). Also known as: Emtriva.
Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI) that blocks HIV reverse transcriptase, preventing viral RNA from being converted into DNA and integrated into host cells.
Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI) that blocks HIV reverse transcriptase, preventing viral RNA from being converted into DNA and integrated into host cells. Used for HIV-1 infection (as part of combination antiretroviral therapy), HIV-1 pre-exposure prophylaxis (PrEP).
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Anti-infectives pathway favourability
+2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | Emtricitabine (FTC) |
|---|---|
| Also known as | Emtriva |
| Sponsor | National University Hospital, Singapore |
| Drug class | Nucleoside reverse transcriptase inhibitor (NRTI) |
| Target | HIV reverse transcriptase |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Virology |
| Phase | Phase 3 |
Mechanism of action
Emtricitabine is a cytidine analog that inhibits HIV reverse transcriptase by competing with natural nucleotides and causing chain termination during viral DNA synthesis. It is incorporated into the growing DNA chain, preventing further elongation and effectively blocking HIV replication. The drug is commonly used as part of combination antiretroviral therapy (cART) regimens.
Approved indications
- HIV-1 infection (as part of combination antiretroviral therapy)
- HIV-1 pre-exposure prophylaxis (PrEP)
Common side effects
- Headache
- Diarrhea
- Nausea
- Fatigue
- Rash
- Hyperpigmentation (palms/soles)
Key clinical trials
- Spotting Syphilis: A Dual Point-of-Care Syphilis Screening Initiative in a Low-Resource Healthcare Setting (NA)
- A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062) (PHASE2, PHASE3)
- Switch to Doravirine/Islatravir (DOR/ISL) in Human Immunodeficiency Virus 1 (HIV-1) Participants Treated With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-018) (PHASE3)
- ImPrEP LEN Brasil: Twice-Yearly Lenacapavir for HIV Prevention (NA)
- Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination in Adolescents and Children With Human Immunodeficiency Virus-1 (PHASE2, PHASE3)
- Exploration of the Variability of Exposure to Antiretroviral Treatment in Hair With a View to Validating Its Value as a Diagnostic Tool for Partial and/or Total Non-compliance With Treatment
- A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010) (PHASE3)
- Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIV (PHASE2, PHASE3)
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:
- Emtricitabine (FTC) CI brief — competitive landscape report
- Emtricitabine (FTC) updates RSS · CI watch RSS
- National University Hospital, Singapore portfolio CI
Frequently asked questions about Emtricitabine (FTC)
What is Emtricitabine (FTC)?
How does Emtricitabine (FTC) work?
What is Emtricitabine (FTC) used for?
Who makes Emtricitabine (FTC)?
Is Emtricitabine (FTC) also known as anything else?
What drug class is Emtricitabine (FTC) in?
What development phase is Emtricitabine (FTC) in?
What are the side effects of Emtricitabine (FTC)?
What does Emtricitabine (FTC) target?
Related
- Drug class: All Nucleoside reverse transcriptase inhibitor (NRTI) drugs
- Target: All drugs targeting HIV reverse transcriptase
- Manufacturer: National University Hospital, Singapore — full pipeline
- Therapeutic area: All drugs in Infectious Disease / Virology
- Indication: Drugs for HIV-1 infection (as part of combination antiretroviral therapy)
- Indication: Drugs for HIV-1 pre-exposure prophylaxis (PrEP)
- Also known as: Emtriva
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing