Last reviewed 2026-05-19 · How we verify

Combi 0.3 group

ANRS, Emerging Infectious Diseases · Phase 1 active Biologic ✓ Verified May 2026

Combi 0.3 group is a Biologic drug developed by ANRS, Emerging Infectious Diseases. It is currently in Phase 1 development.

Combi 0.3 is a vaccine component that induces an immune response, as part of a dose escalation trial in healthy adults. The trial involves evaluating different doses of Combi 0.3, including a Solo 0.3 group, in combination with a DNA-HIV-PT123 HIV-1 vaccine.

Likelihood of approval

9.6% 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).

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	Combi 0.3 group
Sponsor	ANRS, Emerging Infectious Diseases
Modality	Biologic
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Combi 0.3 group CI brief — competitive landscape report
Combi 0.3 group updates RSS · CI watch RSS
ANRS, Emerging Infectious Diseases portfolio CI

Frequently asked questions about Combi 0.3 group

What is Combi 0.3 group?

Combi 0.3 group is a Biologic drug developed by ANRS, Emerging Infectious Diseases.

Who makes Combi 0.3 group?

Combi 0.3 group is developed by ANRS, Emerging Infectious Diseases (see full ANRS, Emerging Infectious Diseases pipeline at /company/anrs-emerging-infectious-diseases).

What development phase is Combi 0.3 group in?

Combi 0.3 group is in Phase 1.

Manufacturer: ANRS, Emerging Infectious Diseases — full pipeline

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