Last reviewed 2026-05-18 · How we verify

EFZ EMT TDF

Sanofi · Phase 1 active Small molecule Quality 55/100

EFZ EMT TDF is a Fixed-dose combination antiretroviral therapy Small molecule drug developed by Sanofi. It is currently in Phase 1 development. Also known as: ATRIPLA™.

Combines an NNRTI, nucleoside reverse transcriptase inhibitor, and nucleotide reverse transcriptase inhibitor to block HIV replication at multiple steps.

Likelihood of approval

12.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

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).
Big-pharma sponsor +3.0pp
Sanofi is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.

Predicted approval windows by jurisdiction (conditional on FDA approval)

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	EFZ EMT TDF
Also known as	ATRIPLA™
Sponsor	Sanofi
Drug class	Fixed-dose combination antiretroviral therapy
Modality	Small molecule
Phase	Phase 1

Mechanism of action

Efavirenz is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that binds directly to reverse transcriptase. Emtricitabine and tenofovir are nucleoside/nucleotide analogs that competitively inhibit HIV reverse transcriptase and terminate viral DNA chain elongation. The combination provides synergistic antiviral activity through complementary mechanisms.

Approved indications

Common side effects

No common side effects on file.

Key clinical trials

Interaction Study to Assess the Pharmacokinetic Interaction of Oral Administration of Rifapentine on ATRIPLA™ in HIV Patients (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:

EFZ EMT TDF CI brief — competitive landscape report
EFZ EMT TDF updates RSS · CI watch RSS
Sanofi portfolio CI

Frequently asked questions about EFZ EMT TDF

What is EFZ EMT TDF?

EFZ EMT TDF is a Fixed-dose combination antiretroviral therapy drug developed by Sanofi.

How does EFZ EMT TDF work?

Combines an NNRTI, nucleoside reverse transcriptase inhibitor, and nucleotide reverse transcriptase inhibitor to block HIV replication at multiple steps.

Who makes EFZ EMT TDF?

EFZ EMT TDF is developed by Sanofi (see full Sanofi pipeline at /company/sanofi).

Is EFZ EMT TDF also known as anything else?

EFZ EMT TDF is also known as ATRIPLA™.

What drug class is EFZ EMT TDF in?

EFZ EMT TDF belongs to the Fixed-dose combination antiretroviral therapy class. See all Fixed-dose combination antiretroviral therapy drugs at /class/fixed-dose-combination-antiretroviral-therapy.

What development phase is EFZ EMT TDF in?

EFZ EMT TDF is in Phase 1.

Drug class: All Fixed-dose combination antiretroviral therapy drugs
Manufacturer: Sanofi — full pipeline
Also known as: ATRIPLA™

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing