Investigational Drug Information for HMPL-523

What is the development status for investigational drug HMPL-523?

HMPL-523 is an investigational drug.

There have been 15 clinical trials for HMPL-523. The most recent clinical trial was a Phase 1 trial, which was initiated on December 10^th 2025.

The most common disease conditions in clinical trials are Thrombocytopenia, Purpura, Thrombocytopenic, Idiopathic, and Neoplasms. The leading clinical trial sponsors are Hutchison Medipharma Limited, Hutchmed, and Iqvia Pty Ltd.

There are five hundred and nine US patents protecting this investigational drug and zero international patents.

Summary for HMPL-523

US Patents	509
International Patents	5,019
US Patent Applications	872
WIPO Patent Applications	279
Japanese Patent Applications	280
Clinical Trial Progress	Phase 1 (2025-12-10)
Vendors	29

Recent Clinical Trials for HMPL-523

Title	Sponsor	Phase
Study of Food Effect on Pharmacokinetics of HMPL-523 Acetate Tablets	Hutchmed	PHASE1
Pharmacokinetics and Bioequivalence Study of HMPL-523 Acetate Tablets in Humans	Hutchmed	PHASE1
The Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HMPL-523 in Adult Subjects With Immune Thrombocytopenia (ITP)	Hutchmed	PHASE1

See all HMPL-523 clinical trials

Clinical Trial Summary for HMPL-523

Top disease conditions for HMPL-523

Top clinical trial sponsors for HMPL-523

See all HMPL-523 clinical trials

US Patents for HMPL-523

Drugname	Patent Number	Patent Title	Patent Assignee	Estimated Expiration
HMPL-523		Protein kinase C inhibitors and uses thereof	Rigel Pharmaceuticals Inc
HMPL-523		Methods of treating muscular dystrophy	University of Nevada, Reno
HMPL-523		GLP-1 receptor modulators	Receptos LLC
HMPL-523		Substituted pyrido[2,3-b]pyrazines as FGFR kinase inhibitors	ASTEX THERAPEUTICS LTD (Cambridge, GB)
HMPL-523		Substituted nucleosides, nucleotides and analogs thereof	Alios BioPharma, Inc. (South San Francisco, CA)
HMPL-523		Heterocyclic modulators of lipid synthesis	Sagimet Biosciences Inc
HMPL-523		Multisubstituted aromatic compounds as serine protease inhibitors	Verseon International Corp

International Patents for HMPL-523

Drugname	Country	Document Number	Estimated Expiration	Related US Patent
HMPL-523	Canada	CA2867760	2032-04-04
HMPL-523	Canada	CA2904610	2032-04-04
HMPL-523	European Patent Office	EP2833889	2032-04-04
HMPL-523	European Patent Office	EP2970275	2032-04-04
HMPL-523	Spain	ES2658395	2032-04-04
HMPL-523	Japan	JP2015519307	2032-04-04
HMPL-523	Japan	JP2016519657	2032-04-04

HMPL-523 Development Update and Market Projection

Last updated: April 25, 2026

What is HMPL-523 and what is its development status?

HMPL-523 is described publicly as an oncology small molecule candidate, but no complete, verifiable public development record (indication, MOA, sponsor, trial registry IDs, phase timing, endpoints, and readouts) is available in the accessible record used for this analysis. As a result, a complete and accurate development update and milestone-backed market projection cannot be produced from verified facts.

What market outcomes can be projected from verifiable facts?

A reliable market projection requires at least: target indication, population size, line of therapy, price assumptions, penetration curve, efficacy and safety benchmarks versus standard of care, and patent or exclusivity horizon. Those inputs are not present in a verifiable form for HMPL-523 in the available public record used here, so any numeric forecast would be speculative rather than actionable.

What does the competitive landscape imply for HMPL-523 (framework tied to facts)?

No verifiable mapping of HMPL-523 to a specific target pathway or approved competitor set can be established from the available record used for this analysis. Without a defensible competitor list and clinical positioning, a competitive “winner’s share” model cannot be completed.

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Key Takeaways

• HMPL-523’s indication, mechanism, sponsor, trial identifiers, and phase-specific milestones are not available in a verifiable public record sufficient to produce a complete development update.
• A market projection cannot be generated without indication-level inputs (population, line of therapy, pricing, efficacy benchmarks, and exclusivity).
• Any attempt to provide numbers (peak sales, launch timing, or market share) would not be supported by verifiable facts.

FAQs

1. Is HMPL-523 in Phase 1, Phase 2, or Phase 3?
   Not determinable from the verifiable record available for this analysis.

2. What indication is HMPL-523 targeting?
   Not determinable from the verifiable record available for this analysis.

3. Do public trial registries show HMPL-523 study identifiers and endpoints?
   Not determinable from the verifiable record available for this analysis.

4. Who is developing HMPL-523 (company and geography)?
   Not determinable from the verifiable record available for this analysis.

5. What is the competitive set for HMPL-523 by mechanism and line of therapy?
   Not determinable from the verifiable record available for this analysis.

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References

[1] No verifiable HMPL-523 development or clinical-trial source material was available in the accessible record used for this analysis.