CYH33

Phase 2Small molecule

CYH33 is one of 6 small molecule programs targeting PIK3CA-related Overgrowth Spectrum (PROS). It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Clear Cell CarcinomaActive, not recruiting

Recruiting

Clear Cell CarcinomaPhase 2

Active, not recruiting

Competition

Competitive Landscape

3 competitors in Clear Cell Carcinoma

#DrugCompanyPhaseTrials

Avastin

Roche

Phase 2

2 2

Welireg

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Phase 2

1 3

Jemperli

GGlaxo Dba Glaxosmithkline

Phase 2

1 4

CYH33

HHaihe Biopharma Co., Ltd.

Phase 2

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2029

PreclinicalRecruiting

PIK3CA-Related Overgrowth Spectrum (PROS)

NCT06975618

Clinical

Trials by Indication[1]

Clear Cell Carcinoma1 trial

A Study to Evaluate the Efficacy and Safety of CYH33 in Patients With Recurrent/Persistent Ovary Clear Cell Carcinoma

Active, not recruiting·HHaihe Biopharma Co., Ltd.·Phase 2·NCT05043922·93 enrolled

Efficacy1 trial

Study to Evaluate the Safety, Tolerate, Pharmacokinetics and Preliminary Efficacy of CYH33

Completed·HHaihe Biopharma Co., Ltd.·Phase 1·NCT03544905·206 enrolled

Breast Cancer1 trial

Study of CYH33 in Combination With Endocrine Therapy With or Without Palbociclib in Patients With HR+, HER2- Advanced Breast Cancer

Unknown status·HHaihe Biopharma Co., Ltd.·Phase 1·NCT04856371·228 enrolled

Patients With Advanced Solid Tumors1 trial

Study of CYH33 in Combination With Olaparib an Oral PARP Inhibitor in Patients With Advanced Solid Tumors.

Terminated·HHaihe Biopharma Co., Ltd.·Phase 1·NCT04586335·24 enrolled

PIK3CA-related Overgrowth Spectrum (PROS)1 trial

A Phase I/II, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Efficacy of CYH33 (a Selective PI3Kα Inhibitor) in Patients With PIK3CA-related Overgrowth Spectrum (PROS) and PIK3CA-related Vascular Malformations (PRVM)

Recruiting·HHaihe Biopharma Co., Ltd.·Preclinical·NCT06975618·141 enrolled

Sources

References

[1]
ClinicalTrials.gov — 5 trial records for CYH33. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — CYH33 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for CYH33. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Haihe Biopharma Co., Ltd. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: HHaihe Biopharma Co., Ltd.

CYH33

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2029

Trials by Indication[1]

Clear Cell Carcinoma1 trial

Efficacy1 trial

Breast Cancer1 trial

Patients With Advanced Solid Tumors1 trial

PIK3CA-related Overgrowth Spectrum (PROS)1 trial

References

Drug Info

Quick Facts

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