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Dihydroergotamine

Generic Name
Dihydroergotamine
Brand Names
Dhe-45, Migranal, Trudhesa
Drug Type
Small Molecule
Chemical Formula
C33H37N5O5
CAS Number
511-12-6
Unique Ingredient Identifier
436O5HM03C
Background

A 9,10alpha-dihydro derivative of ergotamine. Dihydroergotamine is used as an abortive therapy for migraines. Its use has largely been supplanted by triptans in current therapy due to the class's greater selectivity and more favourable side effect profile.

Recent improvements have been made in the design of intranasal delivery devices allowing for greater delivery of dihydroergotamine solution to the vasculature-rich upper nasal cavity. The recently approved Precision Olfactory Delivery technology developed by Impel Neuropharma technology has correlated with an increase of 3-fold in Cmax and 4-fold in AUC despite the solution formulated at 75% of the strength of the existing intranasal product.

Indication

Dihydroergotamine (DHE) in all formulations is indicated for the acute treatment of migraine with or without aura in adults. As an injection, DHE is also indicated for the acute treatment of cluster headache episodes.

DHE is not indicated for migraine prevention or the management of hemiplegic or basilar migraine.

Associated Conditions
Cluster Headache, Migraine Headache, With or Without Aura
Associated Therapies
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pharmaphorum.com
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FDA turns down Satsuma’s nasal migraine treatment

Satsuma Pharmaceuticals faces FDA approval delays for STS101, a dry powder intranasal migraine therapy, due to manufacturing issues. Competing with Impel Neuropharma's Trudhesa and Bausch Health's Migranal, STS101 aims to improve on Migranal's limitations. Despite setbacks, Satsuma plans to resubmit after addressing FDA concerns, without new clinical trials.
synapse.patsnap.com
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FDA Accepts Satsuma and SNBL's Resubmitted NDA for STS101, a Nasal DHE Formulation for Migraine Treatment

Satsuma Pharmaceuticals' resubmitted NDA for STS101, a nasal DHE formulation for migraine treatment, accepted by FDA with a decision expected by April 30, 2025. STS101 offers rapid migraine relief through a proprietary nasal device. Satsuma, a SNBL subsidiary, focuses on innovative migraine treatments, while SNBL, a leading CRO, advances drug delivery technologies and community well-being.
prnewswire.com
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Satsuma Pharmaceuticals and SNBL Announce Promising Results for Novel Nasal Powder Migraine Treatment

STS101, a novel nasal powder for migraine treatment, showed a favorable safety profile and rapid symptom relief in the ASCEND Phase 3 trial. It was well tolerated, with 37% achieving pain freedom and 54% symptom freedom at 2 hours, sustaining benefits over 48 hours. Satsuma Pharmaceuticals seeks FDA approval for STS101.
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