SPH4336

Phase 3Small molecule

SShanghai Pharmaceuticals Holding Co., Ltd

SPH4336 is one of 66 small molecule programs targeting Solid Tumor. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Solid TumorRecruiting

Breast CancerRecruiting

Solid TumorPreclinical

Recruiting

Breast CancerPhase 3

Recruiting

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

SPH4336

SShanghai Pharmaceuticals Holding Co., Ltd

Phase 3

3 2

Lexiscan

Astellas

Preclinical

1 3

Blenoxane

Bristol-Myers Squibb

Preclinical

1 4

Sporanox

SSebela Pharmaceuticals Development LLC

Preclinical

1 5

Feraheme

AAzurity Pharmaceuticals

Preclinical

1 6

Vfend

PPrism Pharmaceuticals

Systemic Therapy

1 8

Neoadjuvant Treatment

SShanghai Zhongshan Hospital

Preclinical

1 9

Ablavar

LLantheus Medical Imaging

Preclinical

2 10

Metfomin

UUniversity of Texas Southwestern Medical Center

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Phase 2/3Recruiting

Breast Cancer

NCT05860465

PreclinicalRecruiting

Solid Tumor

NCT05944224

Clinical

Trials by Indication[1]

Breast Cancer3 trials

Safety and Efficacy of SPH4336 in Combination With Endocrine Therapy in the Treatment of Locally Advanced or Metastatic Breast Cancer

Recruiting·SShanghai Pharmaceuticals Holding Co., Ltd·Phase 2/3·NCT05860465·254 enrolled

Phase II/III Study of SPH4336 Combined With Letrozole vs Placebo Combined With Letrozole in First-line Treatment of Breast Cancer

Recruiting·SShanghai Pharmaceuticals Holding Co., Ltd·Phase 2/3·NCT05744687·374 enrolled

Efficacy and Safety of SPH4336 in Combination With Endocrine Therapy in Breast Cancer Patients With Brain Metastases.

Recruiting·SShanghai Pharmaceuticals Holding Co., Ltd·Phase 2·NCT05872347·52 enrolled

Liposarcoma1 trial

Open-Label Study of the CDK4/6 Inhibitor SPH4336 in Subjects With Locally Advanced or Metastatic Liposarcomas

Terminated·SShanghai Pharma Biotherapeutics USA Inc.·Phase 2·NCT05580588·14 enrolled

Advanced Solid Tumors1 trial

Phase I Clinical Study of SPH4336 Tablets in the Treatment of Advanced Solid Tumors

Completed·SShanghai Pharmaceuticals Holding Co., Ltd·Phase 1/2·NCT05905614·29 enrolled

Solid Tumor1 trial

A Randomized, Open-label, Phase Ib/IIa Clinical Study to Evaluate the Efficacy and Safety of SPH4336 Monotherapy or in Combination With Cadonilimab in Patients With Advanced Solid Tumors, Including Advanced Well Differentiated/Dedifferentiated Liposarcoma.

Recruiting·SShanghai Pharmaceuticals Holding Co., Ltd·Preclinical·NCT05944224·63 enrolled

Sources

References

[1]
ClinicalTrials.gov — 6 trial records for SPH4336. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — SPH4336 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for SPH4336. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Shanghai Pharmaceuticals Holding Co., Ltd company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: SShanghai Pharmaceuticals Holding Co., Ltd

SPH4336

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Trials by Indication[1]

Breast Cancer3 trials

Liposarcoma1 trial

Advanced Solid Tumors1 trial

Solid Tumor1 trial

References

Drug Info

Quick Facts

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