Last reviewed 2026-06-03 · How we verify

TMB-380

TaiMed Biologics Inc. · Phase 2 active Small molecule ✓ Verified Jun 2026

TMB-380 is a Small molecule drug developed by TaiMed Biologics Inc.. It is currently in Phase 2 development. Also known as: VRC07-523LS.

TMB-380 is a small molecule being studied as a potential treatment for HIV-1 infection. It is being investigated in combination with TMB-365 as maintenance therapy in a Phase 2b study.

Likelihood of approval

15.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 2 → approval rate +15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% 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	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+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	TMB-380
Also known as	VRC07-523LS
Sponsor	TaiMed Biologics Inc.
Modality	Small molecule
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

HIV-1 Virologic Suppression With TMB-365 and TMB-380 Antibodies Study (PHASE2)
TMB-365 and TMB-380 in Suppressed HIV-1 Infected Individuals (PHASE1, PHASE2)

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:

TMB-380 CI brief — competitive landscape report
TMB-380 updates RSS · CI watch RSS
TaiMed Biologics Inc. portfolio CI

Frequently asked questions about TMB-380

What is TMB-380?

TMB-380 is a Small molecule drug developed by TaiMed Biologics Inc..

Who makes TMB-380?

TMB-380 is developed by TaiMed Biologics Inc. (see full TaiMed Biologics Inc. pipeline at /company/taimed-biologics-inc).

Is TMB-380 also known as anything else?

TMB-380 is also known as VRC07-523LS.

What development phase is TMB-380 in?

TMB-380 is in Phase 2.

Manufacturer: TaiMed Biologics Inc. — full pipeline
Also known as: VRC07-523LS

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