TVB-2640

Phase 2Small molecule

SSagimet Biosciences Inc.

TVB-2640 is one of 43 small molecule programs targeting Non-Small Cell Lung Carcinoma. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Non-Small Cell Lung CarcinomaActive, not recruiting

Non-Small Cell Lung CarcinomaPhase 2

Active, not recruiting

Competition

Competitive Landscape

45 competitors in Non-Small Cell Lung Carcinoma

#DrugCompanyPhaseTrials

Tabrecta

Novartis

Approved

1 2

Retevmo

Lumakras

Rozlytrek

Keytruda

6 6

Krazati

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Tepmetko

Tagrisso

2 9

Imjudo

AstraZeneca

Phase 3

1 10

Platinol

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Phase 3

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

Timeline

Expected Milestones

Q4 2026

Phase 2Active, not recruiting

Non-Small Cell Lung Carcinoma

NCT03808558

Q1 2028

Phase 1Active, not recruiting

Prostatic Neoplasms, Castration-Resistant

NCT05743621

Clinical

Trials by Indication[1]

Non-Small Cell Lung Carcinoma1 trial

Phase 2 Study of TVB-2640 in KRAS Non-Small Cell Lung Carcinomas

Active, not recruiting·DDavid E Gerber·Phase 2·NCT03808558·18 enrolled

Patients With Solid Tumors1 trial

A Phase 1, First-In-Human Study of Escalating Doses of Oral TVB-2640 in Patients With Solid Tumors

Completed·SSagimet Biosciences Inc.·Phase 1·NCT02223247·180 enrolled

Non-Alcoholic Steatohepatitis1 trial

Study of TVB-2640 in Subjects With Non-Alcoholic Steatohepatitis (NASH)

Completed·SSagimet Biosciences Inc.·Phase 2·NCT03938246·142 enrolled

Hepatic Impairment1 trial

A Phase I Pharmacokinetic Study of TVB-2640 (Denifanstat) in Subjects With Mild, Moderate, or Severe Hepatic Impairment Compared to Subjects With Normal Hepatic Function

Completed·SSagimet Biosciences Inc.·Phase 1·NCT05835180·48 enrolled

Colon Cancer1 trial

TVB 2640 for Resectable Colon Cancer Other Resectable Cancers; a Window Trial.

Terminated·MMark Evers·Phase 1·NCT02980029·23 enrolled

4 more indications

Astrocytoma1 trial

TVB- 2640 in Combination With Bevacizumab in Patients With First Relapse of High Grade Astrocytoma

Completed·TThe University of Texas Health Science Center at San Antonio·Phase 2·NCT03032484·25 enrolled

Hepatitis1 trial

Study of TVB-2640 in Subjects With Nonalcoholic Steatohepatitis (NASH)

Completed·SSagimet Biosciences Inc.·Phase 2·NCT04906421·168 enrolled

Prostatic Neoplasms, Castration-Resistant1 trial

A Phase I, Open-Label, Dose-Finding Study of TVB-2640 Administered in Combination With Enzalutamide (Xtandi) in Men With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Active, not recruiting·WWeill Medical College of Cornell University·Phase 1·NCT05743621·8 enrolled

Unspecified1 trial

Ascending Single-dose Study to Evaluate TVB-2640 in Chinese Healthy Subjects

Completed·AAscletis Pharmaceuticals Co., Ltd.·Phase 1·NCT04352361·34 enrolled

Sources

References

[1]
ClinicalTrials.gov — 9 trial records for TVB-2640. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — TVB-2640 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for TVB-2640. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Sagimet Biosciences Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: SSagimet Biosciences Inc.

TVB-2640

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2028

Trials by Indication[1]

Non-Small Cell Lung Carcinoma1 trial

Patients With Solid Tumors1 trial

Non-Alcoholic Steatohepatitis1 trial

Hepatic Impairment1 trial

Colon Cancer1 trial

Astrocytoma1 trial

Hepatitis1 trial

Prostatic Neoplasms, Castration-Resistant1 trial

Unspecified1 trial

References

Drug Info

Quick Facts

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