Last reviewed 2026-04-19 · How we verify

DPPG2-TSL-DOX

Thermosome GmbH · Phase 1 active Small molecule

DPPG2-TSL-DOX is a Small molecule drug developed by Thermosome GmbH. It is currently in Phase 1 development. Also known as: Doxorubicin, THE001.

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	DPPG2-TSL-DOX
Also known as	Doxorubicin, THE001
Sponsor	Thermosome GmbH
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:

DPPG2-TSL-DOX CI brief — competitive landscape report
DPPG2-TSL-DOX updates RSS · CI watch RSS
Thermosome GmbH portfolio CI

Frequently asked questions about DPPG2-TSL-DOX

What is DPPG2-TSL-DOX?

DPPG2-TSL-DOX is a Small molecule drug developed by Thermosome GmbH.

Who makes DPPG2-TSL-DOX?

DPPG2-TSL-DOX is developed by Thermosome GmbH (see full Thermosome GmbH pipeline at /company/thermosome-gmbh).

Is DPPG2-TSL-DOX also known as anything else?

DPPG2-TSL-DOX is also known as Doxorubicin, THE001.

What development phase is DPPG2-TSL-DOX in?

DPPG2-TSL-DOX is in Phase 1.

Manufacturer: Thermosome GmbH — full pipeline
Also known as: Doxorubicin, THE001

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