Turalio

(Pexidartinib)

Phase 3Small molecule

Daiichi Sankyo

Turalio is one of 100 small molecule programs targeting Giant Cell Tumor. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Giant Cell TumorActive, not recruiting

Colorectal CancerActive, not recruiting

Gastrointestinal Stromal TumorActive, not recruiting

Tenosynovial Giant Cell TumorActive, not recruiting

Giant Cell TumorPhase 2

Active, not recruiting

Colorectal CancerPhase 1

Active, not recruiting

Gastrointestinal Stromal TumorPhase 1

Active, not recruiting

Tenosynovial Giant Cell TumorPhase 3

Active, not recruiting

Competition

Competitive Landscape

949 competitors in Colorectal Cancer

#DrugCompanyPhaseTrials

Turalio

Daiichi Sankyo

Phase 3

1 2

Eylea

Regeneron

Preclinical

5 3

Emend IV

PORTRAZZA

Ketalar

AAultman Health Foundation

Preclinical

1 6

Xylocaine

MMEDRx USA, Inc.

Preclinical

1 7

Versed

CConrado Roberto Hoffmann Filho

Preclinical

1 8

Ultiva

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

Preclinical

1 9

Bridion

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

Preclinical

1 10

Andriol

AAuxilium

Preclinical

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

Timeline

Expected Milestones

Q1 2027

Phase 3Active, not recruiting

Tenosynovial Giant Cell Tumor

NCT04488822

Clinical

Trials by Indication[1]

Advanced Solid Tumors2 trials

CGT9486 (Formerly Known as PLX9486) as a Single Agent and in Combination With PLX3397 (Pexidartinib) or Sunitinib in Participants With Advanced Solid Tumors

Completed·CCogent Biosciences, Inc.·Phase 1/2·NCT02401815·51 enrolled

Study of Pexidartinib in Asian Subjects With Advanced Solid Tumors

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 1·NCT02734433·12 enrolled

Tics2 trials

Effect of Pexidartinib on the Way the Body Processes CYP3A4 and CYP2C9 Substrates (Pharmacokinetics)

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 1·NCT03291288·32 enrolled

Effect of Probenecid on Pexidartinib Pharmacokinetics

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 1·NCT03138759·16 enrolled

Giant Cell Tumor2 trials

Study to Evaluate Discontinuation and Re-Treatment in Participants With Tenosynovial Giant Cell Tumor (TGCT) Previously Treated With Pexidartinib

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 4·NCT04526704·32 enrolled

Phase 3 Study of Pexidartinib for Pigmented Villonodular Synovitis (PVNS) or Giant Cell Tumor of the Tendon Sheath (GCT-TS)

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 3·NCT02371369·120 enrolled

Tenosynovial Giant Cell Tumor2 trials

Multicenter, Single Arm Study of the Efficacy and Safety of Pexidartinib in Adult Subjects With Tenosynovial Giant Cell Tumor

Active, not recruiting· Daiichi Sankyo logo

Daiichi Sankyo·Phase 3·NCT04488822·40 enrolled

A Phase 2, Multicenter, Two-Part, Open-Label Study of Pexidartinib in Adult Subjects With Tenosynovial Giant Cell Tumor in Japan

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 2·NCT04703322·9 enrolled

Gastrointestinal Stromal Tumor1 trial

A Study of MEK162 (Binimetinib) in Combination With Pexidartinib in Patients With Advanced Gastrointestinal Stromal Tumor (GIST)

Completed·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT03158103·3 enrolled

2 more indications

Colorectal Cancer1 trial

Evaluation of Safety and Activity of an Anti-PDL1 Antibody (DURVALUMAB) Combined With CSF-1R TKI (PEXIDARTINIB) in Patients With Metastatic/Advanced Pancreatic or Colorectal Cancers

Completed·CCentre Leon Berard·Phase 1·NCT02777710·48 enrolled

Moderate Hepatic Impairment1 trial

Study of Pexidartinib in Participants With Moderate Hepatic Impairment Compared With Healthy Participants

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 1·NCT04223635·16 enrolled

Regulatory

FDA Approval Timeline[4]

Oct 14, 2022

TURALIO

NDA NDA211810

Sources

References

[1]
ClinicalTrials.gov — 11 trial records for Pexidartinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Pexidartinib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Pexidartinib. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA211810). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Turalio. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Daiichi Sankyo company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Daiichi Sankyo

Patent Landscape[5]

Patent Cliff

Nov 21, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8404700Nov 21, 2027

9169250Nov 21, 2027

8722702Nov 21, 2027

8461169Apr 19, 2028

7893075May 4, 2033

7 more patents

9358235Jun 8, 2033

9802932May 5, 2036

10189833May 5, 2036

10730876May 5, 2036

10941142Jul 24, 2038

10961240Jul 24, 2038

10435404Jul 24, 2038

Turalio

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Trials by Indication[1]

Advanced Solid Tumors2 trials

Tics2 trials

Giant Cell Tumor2 trials

Tenosynovial Giant Cell Tumor2 trials

Gastrointestinal Stromal Tumor1 trial

Colorectal Cancer1 trial

Moderate Hepatic Impairment1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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