STS101 FDA Approval Status

Last updated by Judith Stewart, BPharm on Dec 4, 2024.

FDA Approved: No
Brand name: STS101
Generic name: dihydroergotamine mesylate
Company: Satsuma Pharmaceuticals, Inc.
Treatment for: Migraine

STS101 (dihydroergotamine mesylate) is a proprietary nasal powder formulation of the ergotamine derivative dihydroergotamine mesylate in development for the acute treatment of migraine.

Dihydroergotamine mesylate is a well established migraine treatment with more than 70 years of therapeutic use. It is thought to work in the treatment of migraine through agonist effects at 5-HT_1D receptors.
Dihydroergotamine mesylate is currently FDA approved in injectable and liquid nasal spray dosage forms.
STS101 is a nasal powder formulation that is designed to be easy-to-carry, and quick and easy to self-administer. It is rapid acting, and delivers optimal drug plasma levels that are high enough for robust efficacy, and below those levels associated with adverse events such as nausea and vomiting.

Development timeline for STS101

Date	Article
Nov 26, 2024	Satsuma Pharmaceuticals and SNBL Receive FDA Acceptance of NDA Resubmission of STS101 for the Acute Treatment of Migraine With or Without Aura
Oct 30, 2024	Satsuma Pharmaceuticals and SNBL Resubmits the New Drug Application for STS101 (Dihydroergotamine Nasal Powder) for the Acute Treatment of Migraine With or Without Aura
Jan 18, 2024	FDA Issues Complete Response Letter for Satsuma’s STS101
May 18, 2023	Satsuma Pharmaceuticals Announces FDA Acceptance of 505(b)(2) NDA for STS101, a Novel and Investigational Dihydroergotamine (DHE) Nasal Powder Product for the Acute Treatment of Migraine
Jul 28, 2021	Satsuma Pharmaceuticals Announces First Subject Randomized in SUMMIT™, a Phase 3 Efficacy Trial of STS101 for the Acute Treatment of Migraine
Sep 10, 2020	Satsuma Pharmaceuticals Announces Topline Results from EMERGE Phase 3 Trial of STS101 for the Acute Treatment of Migraine

Further information

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