Last reviewed 2026-05-27 · How we verify

HM71224 food effect

Hanmi Pharmaceutical Company Limited · Phase 1 active Small molecule ✓ Verified May 2026

HM71224 food effect is a Small molecule drug developed by Hanmi Pharmaceutical Company Limited. It is currently in Phase 1 development.

HM71224 is a small molecule inhibitor of the tyrosine-protein kinase BTK. It is being studied in a Phase 1 clinical trial for its safety, tolerability, pharmacokinetics, and pharmacodynamics, including a study of its food effect in healthy adult male volunteers.

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	HM71224 food effect
Sponsor	Hanmi Pharmaceutical Company 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

Safety,PK/PD, Food Effect Study of Orally Administered HM71224 in Healthy Adult 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:

HM71224 food effect CI brief — competitive landscape report
HM71224 food effect updates RSS · CI watch RSS
Hanmi Pharmaceutical Company Limited portfolio CI

Frequently asked questions about HM71224 food effect

What is HM71224 food effect?

HM71224 food effect is a Small molecule drug developed by Hanmi Pharmaceutical Company Limited.

Who makes HM71224 food effect?

HM71224 food effect is developed by Hanmi Pharmaceutical Company Limited (see full Hanmi Pharmaceutical Company Limited pipeline at /company/hanmi-pharmaceutical-company-limited).

What development phase is HM71224 food effect in?

HM71224 food effect is in Phase 1.

Manufacturer: Hanmi Pharmaceutical Company Limited — full pipeline

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