OPDUALAG

(Opdualag)

Phase 2Small molecule

Bristol-Myers Squibb

OPDUALAG is one of 71 small molecule programs targeting Cutaneous Melanoma. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Cutaneous MelanomaRecruiting

AdolescentRecruiting

Locally Advanced or Metastatic Solid TumorsRecruiting

Cutaneous MelanomaPhase 2

Recruiting

AdolescentPhase 2

Recruiting

Locally Advanced or Metastatic Solid TumorsPhase 2

Recruiting

Competition

Competitive Landscape

37 competitors in Locally Advanced or Metastatic Solid Tumors

#DrugCompanyPhaseTrials

Keytruda

Merck & Co.

Phase 2

10 2

Afinitor

Novartis

Phase 2

1 3

Stivarga

Bayer

Phase 2

1 4

OPDUALAG

Bristol-Myers Squibb

Phase 2

1 5

Budigalimab

AbbVie

Phase 1

1 6

BL-M08D1

SSichuan Baili Pharmaceutical Co., Ltd.

Phase 1

1 7

ASKB589

AAskGene Pharma, Inc.

Phase 2

1 8

BC3195

BBiocity Biopharmaceutics Co., Ltd.

Phase 2

1 9

SYHA1813

SShanghai Runshi Pharmaceutical Technology Co., Ltd

Phase 2

1 10

KB707

KKrystal Biotech, Inc.

Phase 2

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

Timeline

Expected Milestones

Q3 2027

Phase 1/2Recruiting

Locally Advanced or Metastatic Solid Tumors

NCT05970497

Q1 2030

Phase 2Recruiting

Cutaneous Melanoma

NCT06319196

Q4 2035

Phase 1/2Recruiting

Adolescent

NCT06208657

Clinical

Trials by Indication[1]

Adolescent1 trial

Optimal Precision TherapIes to CustoMISE Care in Childhood and Adolescent Cancer

Recruiting·AAustralian & New Zealand Children's Haematology/Oncology Group·Phase 1/2·NCT06208657·90 enrolled

Locally Advanced or Metastatic Solid Tumors1 trial

A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors

Recruiting·KKrystal Biotech, Inc.·Phase 1/2·NCT05970497·240 enrolled

Cutaneous Melanoma1 trial

Clear Me: Interception Trial to Detect and Clear Molecular Residual Disease in Patients With High Risk Melanoma

Recruiting·UUniversity Health Network, Toronto·Phase 2·NCT06319196·54 enrolled

Regulatory

FDA Approval Timeline[4]

Mar 18, 2022

OPDUALAG

BLA BLA761234

Sources

References

[1]
ClinicalTrials.gov — 3 trial records for Opdualag. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Opdualag compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Opdualag. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (BLA BLA761234). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Bristol-Myers Squibb company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: Bristol-Myers Squibb

OPDUALAG

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2027

Q1 2030

Q4 2035

Trials by Indication[1]

Adolescent1 trial

Locally Advanced or Metastatic Solid Tumors1 trial

Cutaneous Melanoma1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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