MedPath

Paltusotine

Generic Name
Paltusotine
Brand Names
-
Drug Type
Small Molecule
Chemical Formula
C27H22F2N4O
CAS Number
2172870-89-0
Unique Ingredient Identifier
F2IBD1GMD3
Background

Paltusotine is under investigation in clinical trial NCT04261712 (A Study to Evaluate the Long-term Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Advance)).

Associated Conditions
-
Associated Therapies
-
biospace.com
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Crinetics Announces Positive Topline Results From Phase 2 Trial of Atumelnant in ...

Crinetics Pharmaceuticals announced positive Phase 2 results for atumelnant, showing significant reductions in CAH biomarkers and improvements in clinical signs. The drug was well-tolerated, supporting the initiation of a Phase 3 trial. Atumelnant, a novel ACTH receptor antagonist, demonstrated rapid, substantial reductions in androstenedione and 17-OHP levels.

Crinetics Announces Positive Topline Results From Phase 2 Trial of Atumelnant in Congenital Adrenal Hyperplasia (CAH)

Crinetics Pharmaceuticals announced positive Phase 2 results for atumelnant, showing significant reductions in CAH biomarkers and improvements in symptoms. The drug was well-tolerated, supporting a Phase 3 trial. Atumelnant, a novel ACTH receptor antagonist, demonstrated rapid, substantial biomarker reductions and symptom improvements in CAH patients.
stocktitan.net
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Crinetics' CAH Drug Atumelnant Shows Remarkable 80% Efficacy in Phase 2 Trials

Crinetics announced positive Phase 2 trial results for atumelnant in treating congenital adrenal hyperplasia (CAH), showing significant biomarker reductions and clinical improvements. The drug was well-tolerated, supporting a Phase 3 trial initiation. Crinetics plans further studies in pediatric patients and additional drug candidates.
crinetics.com
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Crinetics Pharmaceuticals Announces Positive Phase 2 Results for Atumelnant

Crinetics Pharmaceuticals announced positive Phase 2 results for atumelnant, showing significant reductions in CAH biomarkers and improvements in symptoms. The drug was well-tolerated, supporting a Phase 3 trial initiation. A conference call to discuss results is scheduled.
globenewswire.com
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Crinetics Announces Positive Topline Results From Phase 2

Crinetics Pharmaceuticals announced positive Phase 2 results for atumelnant, showing significant reductions in CAH biomarkers and improvements in symptoms. The drug was well-tolerated, supporting a Phase 3 trial. Atumelnant, an ACTH receptor antagonist, demonstrated rapid, substantial biomarker reductions, including up to 80% in androstenedione levels.
morningstar.com
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Crinetics Pharmaceuticals Appoints Isabel Kalofonos as Chief Commercial Officer

Crinetics Pharmaceuticals appoints Isabel Kalofonos as Chief Commercial Officer to lead commercial strategy for paltusotine, a potential treatment for acromegaly, and pre-commercialization activities for the company's pipeline.
pharmacytimes.com
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FDA Accepts NDA for Paltusotine to Treat Adult Patients With Acromegaly

The FDA has accepted Crinetics Pharmaceuticals' NDA for paltusotine, an investigational treatment for acromegaly, based on positive data from PATHFNDR-1 and PATHFNDR-2 trials. If approved, paltusotine would be the first once-daily, oral selective somatostatin receptor type 2 nonpeptide agonist for acromegaly patients.
biospace.com
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Crinetics Announces FDA Acceptance of New Drug Application for Paltusotine for Adult Acromegaly

Crinetics Pharmaceuticals announced the FDA accepted its NDA for paltusotine, a potential once-daily oral treatment for acromegaly. The FDA set a target action date of September 25, 2025, and an advisory committee meeting is not anticipated. Paltusotine, an SST2 nonpeptide agonist, aims to offer an alternative to current peptide analog drugs.
nasdaq.com
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Crinetics announces FDA acceptance of NDA for paltusotine

Crinetics Pharmaceuticals' NDA for paltusotine, a once-daily oral treatment for acromegaly, was accepted by the FDA. If approved, it will be the first of its kind, offering an alternative to current peptide analog drugs. Crinetics is preparing for a potential commercial launch.
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