Drugs / Dihydroergotamine

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) D.H.E. 45 1946-04-12 fda.gov

Trials 17 · a red edge is where a trial was stopped

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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 16 trials
Phase 1 NCT07665892 May → Dec 2026 expected Aspeya, Inc. Recruiting No outcome recorded
Phase 1 NCT05351086 Jun → Sep 2022 Pulmatrix Inc. Completed No outcome recorded
Phase 1 NCT03874832 Sep → Nov 2018 migraine with aura, migraine without aura Satsuma Pharmaceuticals, Inc. Completed No outcome recorded
Phase 1 NCT01191723 Aug → Sep 2010 Allergan Completed No outcome recorded
Phase 1 NCT01468558 Jul → Aug 2010 Allergan Completed No outcome recorded
Phase 1 NCT01089062 Mar → Sep 2010 Allergan Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT01199965 Jan → Apr 2010 Allergan Completed No outcome recorded
Phase 21 trial
Phase 2 NCT07646613 May → Dec 2026 expected migraine disorder Aspeya, Inc. Recruiting No outcome recorded
Phase 37 trials
Phase 3 NCT04940390 Jun 2021 → Oct 2022 migraine with aura, migraine without aura Satsuma Pharmaceuticals, Inc. Completed No outcome recorded
Phase 3 NCT02706015 Oct 2020 → May 2021 migraine disorder Ache Laboratorios Farmaceuticos S.A. Withdrawn No outcome recorded
Phase 3 NCT04406649 Sep 2020 → Jan 2023 migraine with aura, migraine without aura Satsuma Pharmaceuticals, Inc. Completed No outcome recorded
Phase 3 NCT02582996 Apr 2020 → Apr 2021 migraine disorder Ache Laboratorios Farmaceuticos S.A. Suspended No outcome recorded
Phase 3 NCT03901482 Jun 2019 → Jul 2020 migraine with aura, migraine without aura Satsuma Pharmaceuticals, Inc. Completed No outcome recorded
Phase 3 NCT03557333 Jul 2018 → Mar 2020 migraine disorder Impel Pharmaceuticals Completed No outcome recorded
Phase 3 NCT00623636 Jul 2008 → Dec 2010 migraine disorder Allergan Completed No outcome recorded
Phase 41 trial
Phase 4 NCT00335777 Aug 2006 → Dec 2008 migraine disorder Thomas Jefferson University Completed No outcome recorded
Phase not applicable1 trial
NCT00203268 Dec 2003 → Mar 2005 migraine disorder Thomas Jefferson University Completed No outcome recorded
Also used as a comparator or background therapy in 4 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 13 trials
Phase 1 NCT07226362 Comparator Jun → Oct 2025 Aspeya Switzerland SA Completed No outcome recorded
Phase 1 NCT05337254 Comparator Mar → Jun 2021 migraine with aura, migraine without aura Satsuma Pharmaceuticals, Inc. Completed No outcome recorded
Phase 1 NCT03401346 Comparator Oct → Dec 2017 migraine disorder Impel Pharmaceuticals Completed No outcome recorded
Phase 21 trial
Phase 2 NCT03885154 Comparator Oct 2017 → Mar 2019 migraine disorder Kimberly S Jones Terminated No outcome recorded

Evidence & citations 22 cited values

Every value below carries the sentence it was read from. 27 sources stand behind the page.

FieldValueCited text
Known as dihydroergotamine “ASY202 is a pre-metered drug-device combination product containing a dry-powder formulation of dihydroergotamine (DHE) intended for oral inhalation, delivered via a dry powder...” NCT07646613
15

“ASY202 is a pre-metered drug-device combination product containing a dry-powder formulation of dihydroergotamine (DHE) intended for oral inhalation, delivered via a dry powder...” NCT07665892

Dihydroergotamine Mesylate (DHE) administered using the I123 Precision Olfactory Delivery (POD) Device” NCT03557333

“MAP0004 is an orally inhaled formulation of dihydroergotamine delivered to the systemic circulation.” PMID 21457235 Apr 2011

Dihydroergotamine Mesylate (DHE) Delivered by Oral Inhalation (MAP0004)” NCT01468558

Dihydroergotamine mesylate+ dipyrone sodium + caffeine” NCT02706015

Dihydroergotamine Mesylate (DHE)” NCT01089062

NCT04406649

NCT03874832

NCT05351086

NCT05337254

NCT02582996

NCT03901482

NCT03401346

NCT04940390

NCT03885154

Known as 9,10-dihydroergotamine ChEMBL registry synonym — accepted as the source's own label CHEMBL1732
Known as DHE “OBJECTIVE: To investigate and compare the safety and the pharmacokinetics of dihydroergotamine (DHE) after administration of intranasal DHE powder (STS101), intranasal DHE...” PMID 31985049 Jan 2020
13

“An Open-Label, 2-Period, Crossover Phase 2 Study Comparing the Pharmacokinetics and Tolerability of Dihydroergotamine Mesylate (DHE) Delivered Intravenously (DHE 45) and by...” NCT01199965

“STS101 is an investigational drug-device combination comprising 5.2 mg dihydroergotamine (DHE) powder (6.0 mg DHE mesylate) in a single-use nasal delivery device for the acute...” PMID 39373843 Oct 2024

“ASY202 is a pre-metered drug-device combination product containing a dry-powder formulation of dihydroergotamine (DHE) intended for oral inhalation, delivered via a dry powder...” NCT07646613

“ASY202 is a pre-metered drug-device combination product containing a dry-powder formulation of dihydroergotamine (DHE) intended for oral inhalation, delivered via a dry powder...” NCT07665892

“OBJECTIVE: MAP0004 is an investigational product which delivers dihydroergotamine (DHE) through the lung via a breath-synchronized metered dose inhaler.” PMID 23926420 Jul 2013

“Single dose 1.45 mg Dihydroergotamine Mesylate (DHE), administered by I123 Precision Olfactory Delivery (POD) device nasal spray (INP104)” NCT03401346

“Single Doses of Dihydroergotamine Mesylate (DHE) Inhalation Powder, DHE Intravenous (IV), and DHE Nasal Spray in Healthy Adult Subjects.” NCT07226362

“Dihydroergotamine Mesylate (DHE) administered using the I123 Precision Olfactory Delivery (POD) Device” NCT03557333

“MAP0004, orally inhaled DHE: a randomized, controlled study in the acute treatment of migraine.” PMID 21457235 Apr 2011

“Dihydroergotamine Mesylate (DHE) Delivered by Oral Inhalation (MAP0004)” NCT01468558

“Dihydroergotamine (DHE) will be given as weight-based dosing” NCT03885154

“intravenous (IV) dihydroergotamine (D.H.E) or IV placebo” NCT05351086

“intranasal dihydroergotamine (DHE) powder (STS101)” PMID 38413540 Feb 2024

Known as DHE-45 “An Open-Label, 2-Period, Crossover Phase 2 Study Comparing the Pharmacokinetics and Tolerability of Dihydroergotamine Mesylate (DHE) Delivered Intravenously (DHE 45) and by...” NCT01199965
1

“dihydroergotamine mesylate (DHE-45).” NCT00203268

Known as Diergo ChEMBL registry synonym — accepted as the source's own label CHEMBL1732
Known as Dihidroergotamina ChEMBL registry synonym — accepted as the source's own label CHEMBL1732
Known as Dihydergot ChEMBL registry synonym — accepted as the source's own label CHEMBL1732
Known as Dihydroergotamine mesilate ChEMBL registry synonym — accepted as the source's own label CHEMBL1732
Known as Dihydroergotamine Mesylate “An Open-Label, 2-Period, Crossover Phase 2 Study Comparing the Pharmacokinetics and Tolerability of Dihydroergotamine Mesylate (DHE) Delivered Intravenously (DHE 45) and by...” NCT01199965
6

“Single dose 1.45 mg Dihydroergotamine Mesylate (DHE), administered by I123 Precision Olfactory Delivery (POD) device nasal spray (INP104)” NCT03401346

“Single Doses of Dihydroergotamine Mesylate (DHE) Inhalation Powder, DHE Intravenous (IV), and DHE Nasal Spray in Healthy Adult Subjects.” NCT07226362

Dihydroergotamine Mesylate (DHE) administered using the I123 Precision Olfactory Delivery (POD) Device” NCT03557333

Dihydroergotamine Mesylate (DHE) Delivered by Oral Inhalation (MAP0004)” NCT01468558

Dihydroergotamine Mesylate (DHE)” NCT01089062

NCT00203268

Known as Dihydroergotamine mesylate component of embolex ChEMBL registry synonym — accepted as the source's own label CHEMBL1732
Known as Dihydroergotamine methanesulfonate ChEMBL registry synonym — accepted as the source's own label CHEMBL1732
Known as MAP0004 “An Open-Label, 2-Period, Crossover Phase 2 Study Comparing the Pharmacokinetics and Tolerability of Dihydroergotamine Mesylate (DHE) Delivered Intravenously (DHE 45) and by...” NCT01199965
2

NCT00623636

NCT01191723

Known as Migranal “OBJECTIVE: To investigate and compare the safety and the pharmacokinetics of dihydroergotamine (DHE) after administration of intranasal DHE powder (STS101), intranasal DHE...” PMID 31985049 Jan 2020
2

“2 mg DHE nasal spray (Migranal®)” NCT07226362

NCT00335777

Known as Neomigran ChEMBL registry synonym — accepted as the source's own label CHEMBL1732
Known as NSC-759848 ChEMBL registry synonym — accepted as the source's own label CHEMBL1732
Known as STS101 “OBJECTIVE: To investigate and compare the safety and the pharmacokinetics of dihydroergotamine (DHE) after administration of intranasal DHE powder (STS101), intranasal DHE...” PMID 31985049 Jan 2020
1

“intranasal dihydroergotamine (DHE) powder (STS101)” PMID 38413540 Feb 2024

Known as Tonopan ChEMBL registry synonym — accepted as the source's own label CHEMBL1732
Known as Trudhesa ChEMBL registry synonym — accepted as the source's own label CHEMBL1732
Action Activate “Serotonin 1d (5-HT1d) receptor agonist” CHEMBL1732
Modality Small molecule CHEMBL1732
Route Intranasal “The study drug is a medication that is taken in the form of nasal spray.” NCT00335777
Target HTR1D “Serotonin 1d (5-HT1d) receptor agonist” CHEMBL1732