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S

SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany

0

Pipeline Programs↗

Distinct drugs in development (Preclinical–Phase 3)

0

Indications↗

Distinct diseases across all programs

8

Clinical Trials↗

All sponsored trials (all statuses)

29

Orange Book Patents

Across 1 drug with upcoming expirations

Activity

Recent Activity

Last 14 days

Active, not recruiting

A Single-arm, Open-label Phase 2 Study of Nirogacestat in Adult Japanese Patients With Progressing Desmoid Tumors/Aggressive Fibromatosis (DT/AF)

A Single-Arm, Open-Label Phase 4 Study of Nirogacestat in Adult Premenopausal Females With Desmoid Tumors/Aggressive Fibromatosis (DT/AF)

Earlier

Sep 3, 2026TrialA Phase 1a/1b Dose Escalation, Dose Expansion Study of SW-682 in Participants With Advanced Solid Tumors Enriched for Those With Hippo Pathway Mutations

Aug 26, 2026TrialA Phase 2 Trial of Nirogacestat in Patients With Recurrent Ovarian Granulosa Cell Tumors

Aug 25, 2026TrialA Phase 1 Open-Label Study to Assess the Pharmacokinetics of Mirdametinib and Its Metabolite PD-0315209 in Participants With Impaired Hepatic Function and Participants With Normal Hepatic Function

Aug 21, 2026TrialA Phase 1/2a Open-Label, Dose Escalation and Expansion Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Mirdametinib in Combination With BGB-3245 in Patients With Advanced Solid Tumors

Aug 21, 2026TrialA Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Nirogacestat Versus Placebo in Adult Patients With Progressing Desmoid Tumors/Aggressive Fibromatosis (DT/AF)

Jul 11, 2026TrialA Phase 2b Trial of the MEK 1/2 Inhibitor (MEKi) PD-0325901 in Adult and Pediatric Patients With Neurofibromatosis Type 1 (NF1)-Associated Inoperable Plexiform Neurofibromas (PNs) That Are Causing Significant Morbidity

1 more events

Nov 27, 2023FDAVivia — OGSIVEO

Details

Company Info

Company Overview

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Revenue

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Patent Expirations

4 patent groups across drugs · Source: FDA Orange Book

DrugExpires

ViviaAug 18, 2030 Vivia10 patentsAug 9, 2039 Vivia8 patentsJul 8, 2042 Vivia10 patentsMay 19, 2043

Regulatory

Regulatory Timeline

20231 event

FDANov 27

Vivia — OGSIVEO

Application NDA217677 (NDA)

Data sources: ClinicalTrials.gov (NIH) · OpenFDA (FDA) · ChEMBL (EMBL-EBI) · Open Targets (EBI/Sanger) · MedlinePlus (NIH) · PubMed (NIH) · SEC EDGAR (SEC)