Last reviewed 2026-06-01 · How we verify

Unlabeled TH-302

Merck KGaA, Darmstadt, Germany · Phase 1 active Small molecule ✓ Verified Jun 2026

Unlabeled TH-302 is a Small molecule drug developed by Merck KGaA, Darmstadt, Germany. It is currently in Phase 1 development.

Unlabeled TH-302 is being studied in a Phase 1 trial for the treatment of solid tumors. The purpose of this trial is to investigate the mass balance and metabolite profile of Unlabeled TH-302.

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
Merck KGaA, Darmstadt, Germany 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	Unlabeled TH-302
Sponsor	Merck KGaA, Darmstadt, Germany
Modality	Small molecule
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:

Unlabeled TH-302 CI brief — competitive landscape report
Unlabeled TH-302 updates RSS · CI watch RSS
Merck KGaA, Darmstadt, Germany portfolio CI

Frequently asked questions about Unlabeled TH-302

What is Unlabeled TH-302?

Unlabeled TH-302 is a Small molecule drug developed by Merck KGaA, Darmstadt, Germany.

Who makes Unlabeled TH-302?

Unlabeled TH-302 is developed by Merck KGaA, Darmstadt, Germany (see full Merck KGaA, Darmstadt, Germany pipeline at /company/merck-kgaa-darmstadt-germany).

What development phase is Unlabeled TH-302 in?

Unlabeled TH-302 is in Phase 1.

Manufacturer: Merck KGaA, Darmstadt, Germany — full pipeline

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