Last reviewed 2026-04-19 · How we verify

HMPL-011 capsules

Hutchison Medipharma Limited · Phase 1 active Small molecule

HMPL-011 capsules is a Small molecule drug developed by Hutchison Medipharma Limited. 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	HMPL-011 capsules
Sponsor	Hutchison Medipharma Limited
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Phase I Clinical Trial in Healthy Male 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:

HMPL-011 capsules CI brief — competitive landscape report
HMPL-011 capsules updates RSS · CI watch RSS
Hutchison Medipharma Limited portfolio CI

Frequently asked questions about HMPL-011 capsules

What is HMPL-011 capsules?

HMPL-011 capsules is a Small molecule drug developed by Hutchison Medipharma Limited.

Who makes HMPL-011 capsules?

HMPL-011 capsules is developed by Hutchison Medipharma Limited (see full Hutchison Medipharma Limited pipeline at /company/hutchison-medipharma-limited).

What development phase is HMPL-011 capsules in?

HMPL-011 capsules is in Phase 1.

Manufacturer: Hutchison Medipharma Limited — full pipeline

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