SPH4336

Phase 3Small molecule

SShanghai Pharmaceuticals Holding Co., Ltd

SPH4336 is one of 61 small molecule programs targeting Breast Cancer. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Breast CancerRecruiting

Solid TumorRecruiting

Breast CancerPhase 3

Recruiting

Solid TumorPreclinical

Recruiting

Competition

Competitive Landscape

706 competitors in Breast Cancer

#DrugCompanyPhaseTrials

SPH4336

SShanghai Pharmaceuticals Holding Co., Ltd

Phase 3

3 2

Lexiscan

Astellas

Preclinical

1 3

Methylthioninium Chloride

PProvepharm SAS

Preclinical

3 4

Vfend

PPrism Pharmaceuticals

Preclinical

—5

Ablavar

LLantheus Medical Imaging

Preclinical

2 6

Naltrexone/bupropion

Novo Nordisk

Preclinical

1 7

Motexafin Gadolinium

PPharmacyclics LLC.

Preclinical

1 8

Sertraline ODT

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

1 9

Liposomal Irinotecan and Apatinib

SSecond Affiliated Hospital, School of Medicine, Zhejiang University

Preclinical

1 10

Midazolam Premedication

YYonsei University

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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