Last reviewed 2026-04-19 · How we verify

Late boost CD40 adjuvanted

ANRS, Emerging Infectious Diseases · Phase 1 active Biologic

Late boost CD40 adjuvanted is a Biologic drug developed by ANRS, Emerging Infectious Diseases. It is currently in Phase 1 development.

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	Late boost CD40 adjuvanted
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.

Key clinical trials

Dose Escalation Trial of CD40.HIVRI.Env Vaccine Combined or Not With a DNA-HIV-PT123 HIV-1 Vaccine in Healthy Volunteers (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:

Late boost CD40 adjuvanted CI brief — competitive landscape report
Late boost CD40 adjuvanted updates RSS · CI watch RSS
ANRS, Emerging Infectious Diseases portfolio CI

Frequently asked questions about Late boost CD40 adjuvanted

What is Late boost CD40 adjuvanted?

Late boost CD40 adjuvanted is a Biologic drug developed by ANRS, Emerging Infectious Diseases.

Who makes Late boost CD40 adjuvanted?

Late boost CD40 adjuvanted is developed by ANRS, Emerging Infectious Diseases (see full ANRS, Emerging Infectious Diseases pipeline at /company/anrs-emerging-infectious-diseases).

What development phase is Late boost CD40 adjuvanted in?

Late boost CD40 adjuvanted is in Phase 1.

Manufacturer: ANRS, Emerging Infectious Diseases — full pipeline

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