Last reviewed 2026-05-20 · How we verify

PEEL-224

Peel Therapeutics Inc · Phase 1 active Small molecule ✓ Verified May 2026 Quality 0/100

PEEL-224 is a Small molecule drug developed by Peel Therapeutics Inc. It is currently in Phase 1 development.

PEEL-224 is being studied in a Phase 1/2 trial for the treatment of relapsed or refractory sarcomas, including Ewing sarcoma, desmoplastic small round cell tumor, and osteosarcoma. The trial is evaluating the safety and efficacy of PEEL-224 in combination with vincristine and temozolomide in adolescents and young adults with these conditions.

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	PEEL-224
Sponsor	Peel Therapeutics Inc
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

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:

PEEL-224 CI brief — competitive landscape report
PEEL-224 updates RSS · CI watch RSS
Peel Therapeutics Inc portfolio CI

Frequently asked questions about PEEL-224

What is PEEL-224?

PEEL-224 is a Small molecule drug developed by Peel Therapeutics Inc.

Who makes PEEL-224?

PEEL-224 is developed by Peel Therapeutics Inc (see full Peel Therapeutics Inc pipeline at /company/peel-therapeutics-inc).

What development phase is PEEL-224 in?

PEEL-224 is in Phase 1.

Manufacturer: Peel Therapeutics Inc — full pipeline

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