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Romvimza

(Vimseltinib)

Phase 3Small molecule

DDeciphera Pharmaceuticals, LLC

Romvimza is one of 14 small molecule programs targeting Male. It is currently in Phase 3.

4

Indications

7

Total Trials

5

Active Trials

13

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

13

Patents

Pipeline

Status by Indication[3][1]

Indication

MaleNot yet recruiting

Advanced Malignant NeoplasmActive, not recruiting

Chronic Graft-Versus-Host Disease (cgvhd)Recruiting

Giant Cell TumorActive, not recruiting

MalePhase 1

Not yet recruiting

Advanced Malignant NeoplasmPreclinical

Active, not recruiting

Chronic Graft-Versus-Host Disease (cgvhd)Phase 2

Recruiting

Giant Cell TumorPhase 3

Active, not recruiting

Competition

Competitive Landscape

8 competitors in Male

#DrugCompanyPhaseTrials

Sensipar

Romvimza

DDeciphera Pharmaceuticals, LLC

Crestor

Pradaxa

Boehringer Ingelheim

Pradaxa

Boehringer Ingelheim

Chf10196

Chiesi Farmaceutici S.p.A.

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

Timeline

Expected Milestones

Q4 2026

Phase 1Recruiting

Study completion

NCT07539090

Phase 1Not yet recruiting

Study completion

NCT07744802

Q3 2028

Phase 3Active, not recruiting

Giant Cell Tumor

NCT05059262

PreclinicalActive, not recruiting

Advanced Malignant Neoplasm

NCT03069469

Q4 2029

Phase 2Recruiting

Chronic Graft-Versus-Host Disease (cgvhd)

NCT06619561

Clinical

Trials by Indication[1]

Giant Cell Tumor1 trial

Study of Vimseltinib for Tenosynovial Giant Cell Tumor

Active, not recruiting·DDeciphera Pharmaceuticals, LLC·Phase 3·NCT05059262·123 enrolled

Tics1 trial

Evaluate the Effect of Vimseltinib on the Pharmacokinetics of a BCRP and OATP1B1 Substrate

Completed·DDeciphera Pharmaceuticals, LLC·Phase 1·NCT07158398·20 enrolled

Chronic Graft-Versus-Host Disease (cGVHD)1 trial

A Study to Evaluate Vimseltinib in Adults With Active Chronic Graft-Versus-Host Disease (cGVHD)

Recruiting·DDeciphera Pharmaceuticals, LLC·Phase 2·NCT06619561·48 enrolled

Organic Cation Transporter 21 trial

Evaluate the Effect of Vimseltinib on Organic Cation Transporter 2 (OCT2)

Completed·DDeciphera Pharmaceuticals, LLC·Phase 1·NCT07158411·22 enrolled

Advanced Malignant Neoplasm1 trial

A Multicenter Phase 1/2, Open-Label Study of DCC-3014 to Assess the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics in Patients With Advanced Tumors and Tenosynovial Giant Cell Tumor

Active, not recruiting·DDeciphera Pharmaceuticals, LLC·Preclinical·NCT03069469·120 enrolled

1 more indication

Unspecified2 trials

A Phase 1, Open-label, Fixed-sequence Study to Evaluate the Effect of Vimseltinib on Pharmacokinetics of Combined Oral Contraceptive (Ethinyl Estradiol/Levonorgestrel) in Healthy Female Participants

Recruiting·DDeciphera Pharmaceuticals, LLC·Phase 1·NCT07539090·24 enrolled

A Phase 1, Open-label, Fixed-sequence Study to Evaluate the Effect of Vimseltinib on P-glycoprotein (P-gp) Inhibition in Healthy Male Participants

Not yet recruiting·DDeciphera Pharmaceuticals, LLC·Phase 1·NCT07744802·20 enrolled

Regulatory

FDA Approval Timeline[4]

Feb 14, 2025

ROMVIMZA

NDA NDA219304

Sources

References

[1]
ClinicalTrials.gov — 7 trial records for Vimseltinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Vimseltinib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Vimseltinib. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA219304). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Romvimza. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Deciphera Pharmaceuticals, LLC company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: DDeciphera Pharmaceuticals, LLC

Patent Landscape[5]

Patent Cliff

Mar 14, 2034

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9181223Mar 14, 2034

12285430Dec 23, 2039

12485120Dec 23, 2039

12582655Dec 23, 2039

11679110Feb 3, 2040

8 more patents

11103507Feb 3, 2040

12617775Dec 6, 2044

12528787Dec 6, 2044

12447149Dec 6, 2044

12551483Dec 6, 2044

12643883Dec 6, 2044

12686672Apr 29, 2045

12509443Apr 30, 2045

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