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SpringWorks Therapeutics, Inc.

Rare disease drugmaker · part of Merck KGaA, Darmstadt, Germany · based in Stamford, United States · springworkstx.com

SpringWorks Therapeutics, Inc. works on 3 rare diseases we track, including Desmoid Tumors, Mesothelioma and 1 more. It has 4 active clinical trials, and 2 are looking for volunteers now. It also has 2 FDA-approved rare disease drugs.

SpringWorks Therapeutics is a rare tumor company based in Stamford, Connecticut, and part of Merck KGaA, Darmstadt, Germany since July 1, 2025.

SpringWorks Therapeutics, Inc. pipeline

Each row lists the diseases SpringWorks Therapeutics, Inc. is studying at that stage, from the ones closest to approval down to the earliest work.

Approved
Drugs the FDA has approved.
Phase 2
Mid-size studies that check whether a drug works and at what dose.
Phase 1
First studies in people, mostly checking safety.

Mesothelioma recruiting

After approval
Studies that follow people already taking an approved drug.

Desmoid Tumors recruiting

SpringWorks Therapeutics, Inc. clinical trials

These are SpringWorks Therapeutics, Inc. trials for the rare diseases we track, from ClinicalTrials.gov. Statuses there can lag behind company news, so confirm with the study team before you plan around one.

2 trials looking for volunteers now

Looking for volunteersPhase 1Recently updatedNCT06251310

SW-682 in Advanced Solid Tumors

Tests SW-682, Combination Therapy

For Advanced Solid Tumor and Mesothelioma, Malignant

This is a first-in-human (FIH), Phase 1a/1b open-label, multicenter, dose escalation and dose expansion study of SW-682 in adult participants with metastatic or unresectable advanced solid tumors with or without Hippo pathway alterations that are refractory to, or have progressed, during or after appropriate prior systemic anticancer therapy, including chemotherapy, immunotherapy, radiation therapy or targeted therapy, or for which no treatment is available, or prior standard of care (SOC) therapy was not tolerated and for which there is no further SOC treatment available. The study includes a Part 1 (Phase 1a) dose escalation phase and a Part 2 (Phase 1b) dose expansion to optimize the dose to be used for further development. All participants will self-administer SW-682 by mouth in 28-day cycles.

Ages 18 Years+8 locations
View full study
Looking for volunteersPhase 4Recently updatedNCT07176689

Nirogacestat in Premenopausal Females With Desmoid Tumor/Aggressive Fibromatosis (DT/AF)

Tests Nirogacestat

For Desmoid Tumor and Aggressive Fibromatosis

This study is being conducted to study how nirogacestat may affect the ovarian function of adult premenopausal women with progressing desmoid tumors/aggressive fibromatosis.

Ages 18 Years - 40 Years23 locations
View full study

2 trials underway, not taking new volunteers

Underway, not taking new volunteersPhase 2Recently updatedNCT03962543

MEK Inhibitor Mirdametinib (PD-0325901) in Patients With Neurofibromatosis Type 1 Associated Plexiform Neurofibromas

Tests Mirdametinib (PD-0325901) oral capsule or dispersible tablet

For Plexiform Neurofibroma and Neurofibromatosis Type 1 (NF1)

This study evaluates mirdametinib (PD-0325901) in the treatment of symptomatic inoperable neurofibromatosis type-1 (NF1)-associated plexiform neurofibromas (PNs). All participants will receive mirdametinib (PD-0325901). Eligible participants may continue in a long-term follow-up phase.

Ages 2 Years+43 locations
View full study
Underway, not taking new volunteersPhase 2Recently updatedNCT07170644

A Study of Nirogacestat in Japanese Adults With Desmoid Tumors/Aggressive Fibromatosis (DT/AF)

Tests Nirogacestat oral tablet

For Desmoid Tumor and Aggressive Fibromatosis

This study is being conducted to characterize the efficacy and safety of nirogacestat in Japanese adults with progressing desmoid tumors/aggressive fibromatosis.

Ages 18 Years+3 locations
View full study
Ask about SpringWorks Therapeutics, Inc.'s trials
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FDA-approved drugs from SpringWorks Therapeutics, Inc.

From the openFDA database. Tap a drug for side effects, dosing and help paying.

Gomekli mirdametinib

For Neurofibromatosis Type 1. Approved Feb 11, 2025.

Ogsiveo nirogacestat

For Desmoid Tumors. Approved Nov 27, 2023. Taken by mouth.

More about SpringWorks Therapeutics, Inc.

It sells Ogsiveo (nirogacestat), approved by the FDA on November 27, 2023 as the first treatment for adults with progressing desmoid tumors who need systemic treatment, and Gomekli (mirdametinib), approved on February 11, 2025 for adults and children 2 and older with symptomatic neurofibromatosis type 1 plexiform neurofibromas that cannot be fully removed by surgery.

It is testing mirdametinib in infants and toddlers with NF1 and an early-stage drug, SW-682, in advanced solid tumors including mesothelioma.

Where SpringWorks Therapeutics, Inc. trials take place

The trials above run at 77 study sites in 8 countries. Tap a country to see its states, cities and hospitals.

United States
51▼
Spain
8▼
Italy
7▼
United Kingdom
4▼
Japan
3▼
Netherlands
2▼
Belgium
1▼
Germany
1▼

Rare diseases SpringWorks Therapeutics, Inc. works on

Each disease page lists every open trial, not only SpringWorks Therapeutics, Inc.'s, plus approved treatments.

Desmoid Tumors

Desmoid tumors are rare growths of fibrous connective tissue that can form almost anywhere in the body.

How common: 2 to 4 new cases per million people each year (NORD; National Cancer Institute)

Mesothelioma

Mesothelioma is a rare, aggressive cancer that develops in the mesothelium, the thin layer of tissue covering most internal organs.

How common: About 3,000 new cases per year in the U.S

Neurofibromatosis Type 1

Neurofibromatosis type 1 is a genetic disorder caused by mutations in the NF1 gene on chromosome 17, which encodes neurofibromin, a tumor suppressor protein.

How common: 1 in 2,500 to 3,500 people in the U.S., making it one of the most common genetic conditions

Where to get support

Patient groups can explain a diagnosis, point you to specialists and tell you about trials before they open. SpringWorks Therapeutics, Inc.'s own site is springworkstx.com, and our help paying for treatment page lists drugmaker programs and charity funds.

Questions about SpringWorks Therapeutics, Inc.