Drugs / Dihydroergotamine
Dihydroergotamine
also known as
D.H.E · Dihydroergotamine Mesylate · MAP0004 · Migranal · DHE-45 · STS101 · 9,10-dihydroergotamine · Diergo · +9 more
Small molecule targets HTR1D via activation
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | D.H.E. 45 | — | 1946-04-12 | fda.gov ↗ |
Trials 17
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials | ||||||
| Phase 1 | NCT07665892 | May 2026 → Mar 2027 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 2026 → Mar 2027 expected | migraine disorder | Aspeya, Inc. | Recruiting | No outcome recorded |
| Phase 37 trials · 1 met primary · 2 missed | ||||||
| Phase 3 | NCT04940390 | Jun 2021 → Oct 2022 | migraine with aura, migraine without aura | Satsuma Pharmaceuticals, Inc. | Completed | Missed primary |
| Phase 3 | NCT02706015 | Oct 2020 → May 2021 | migraine disorder | Ache Laboratorios Farmaceuticos S.A. | Withdrawn | No outcome recorded Stop: Business |
| 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 Stop: Business |
| Phase 3 | NCT03901482 | Jun 2019 → Jul 2020 | migraine with aura, migraine without aura | Satsuma Pharmaceuticals, Inc. | Completed | Missed primary |
| 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 | Met primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT00335777 | Aug 2006 → Dec 2008 | migraine disorder | Thomas Jefferson University | Completed | No outcome recorded |
| Phase not applicable1 trial · 1 missed | ||||||
| — | NCT00203268 | Dec 2003 → Mar 2005 | migraine disorder | Thomas Jefferson University | Completed | Missed primary |
| Comparator or background therapy4 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 2 | NCT03885154 Comparator | Oct 2017 → Mar 2019 | migraine disorder | Kimberly S Jones | Terminated | No outcome recorded Stop: Enrollment |
News releases announcing trial results or a regulatory action · 26
| Date | Issuer | Release |
|---|---|---|
| 2025-11-05 | Satsuma Pharmaceuticals, Inc. | Results Satsuma Pharmaceuticals and SNBL Announce Publication of Impression of Use and Satisfaction with STS101 (Dihydroergotamine Nasal Powder (Atzumi™)) in Headache satsumarx.com ↗
Results show that participant impression through 12 months of treatment indicate STS101 is perceived as favorable across multiple attributes. |
| 2025-04-30 | Satsuma Pharmaceuticals, Inc. | Regulatory Satsuma Pharmaceuticals Announces U.S. FDA Approval for Atzumi™ (Dihydroergotamine) Nasal Powder for the Acute Treatment of Migraine satsumarx.com ↗
Satsuma Pharmaceuticals Announces U.S. FDA Approval for Atzumi™ (Dihydroergotamine) Nasal Powder for the Acute Treatment of Migraine |
| 2024-11-30 | Satsuma Pharmaceuticals, Inc. | Regulatory Satsuma Pharmaceuticals and SNBL Receive FDA Acceptance of NDA Resubmission of STS101 for the Acute Treatment of Migraine With or Without Aura satsumarx.com ↗
Satsuma Pharmaceuticals and SNBL Receive FDA Acceptance of NDA Resubmission of STS101 for the Acute Treatment of Migraine With or Without Aura |
| 2024-10-30 | Satsuma Pharmaceuticals, Inc. | Regulatory Satsuma Pharmaceuticals and SNBL Resubmits the New Drug Application for STS101 (Dihydroergotamine Nasal Powder) for the Acute Treatment of Migraine With or Without Aura satsumarx.com ↗ |
| 2024-10-30 | Satsuma Pharmaceuticals, Inc. | Results Satsuma Pharmaceuticals and SNBL Announce Publication of STS101 (Dihydroergotamine Nasal Powder) Pivotal Phase 3 ASCEND Study in CNS Drugs satsumarx.com ↗
Exploratory Efficacy Endpoints showed that STS101provided rapid freedom from pain (37% of attacks), and rapid freedom from most bothersome symptoms (54% of attacks) at 2 hours and sustained treatment benefits over 48 hours after dosing. |
| 2023-04-30 | Satsuma Pharmaceuticals, Inc. | Results Satsuma Pharmaceuticals Announces Three Abstracts Accepted at The 75th American Academy of Neurology Annual Meeting satsumarx.com ↗
Subject impression data through 12 months suggest that STS101 was perceived very favorably by subjects on multiple measures, including in comparison to their usual migraine medications. |
| 2022-12-30 | Satsuma Pharmaceuticals, Inc. | Results Satsuma Pharmaceuticals Provides STS101 Development Program and Corporate Update satsumarx.com ↗
Further analysis of results from recently-completed SUMMIT Phase 3 efficacy trial of STS101 for the acute treatment of migraine shows differentiating robust and sustained antimigraine effects on clinically important secondary endpoints |
| 2022-11-30 | Satsuma Pharmaceuticals, Inc. | Results Satsuma Pharmaceuticals Announces Topline Results from SUMMIT Phase 3 Trial of STS101 for the Acute Treatment of Migraine satsumarx.com ↗
STS101 was not statistically superior to placebo at two hours post-administration on the co-primary endpoints of freedom from pain and most bothersome symptom |
| 2022-09-30 | Satsuma Pharmaceuticals, Inc. | Results Satsuma Pharmaceuticals Announces Positive Results from the Ongoing STS101 ASCEND Phase 3 Open-label, Long-term Safety Trial satsumarx.com ↗
STS101 demonstrated a favorable safety and tolerability profile, consistent with clinical experience to date |
| 2021-09-03 | Impel Pharmaceuticals | Regulatory Impel NeuroPharma Announces U.S. FDA Approval of TRUDHESA™ (Dihydroergotamine Mesylate) Nasal Spray for the Acute Treatment of Migraine impelpharma.com ↗
today announced that the U.S. Food and Drug Administration (FDA) approved TRUDHESA™ (dihydroergotamine mesylate) nasal spray (0.725 mg per spray) for the acute treatment of migraine with or without aura in adults. |
| 2021-08-10 | Impel Pharmaceuticals | Results Impel NeuroPharma Announces Publication of Pivotal Phase 3, Open-Label Stop 301 Study of INP104 (TRUDHESA™) for Treatment of Acute Migraine in the Journal Headache impelpharma.com ↗
Exploratory Patient-Reported Outcomes Data Indicated More Than One Third of Patients Experienced Pain Freedom and Two Thirds Had Pain Relief Two Hours Following TRUDHESA™ Administration |
| 2021-06-30 | Satsuma Pharmaceuticals, Inc. | Results Satsuma Pharmaceuticals Announces Positive Pharmacokinetic, Tolerability and Safety Results From Phase 1 Trial of STS101 at Multiple Dose Strengths satsumarx.com ↗
The Phase 1 data showed that all three dose strengths (5.2 mg and two higher dose strengths) administered with Satsuma’s improved second-generation nasal delivery device were well-tolerated and achieved the target pharmacokinetic profile. |
| 2021-01-20 | Impel Pharmaceuticals | Regulatory IMPEL NEUROPHARMA ANNOUNCES U.S. FOOD & DRUG ADMINISTRATION ACCEPTANCE OF NEW DRUG APPLICATION FOR INP104 FOR THE ACUTE TREATMENT OF MIGRAINE impelpharma.com ↗
IMPEL NEUROPHARMA ANNOUNCES U.S. FOOD & DRUG ADMINISTRATION ACCEPTANCE OF NEW DRUG APPLICATION FOR INP104 FOR THE ACUTE TREATMENT OF MIGRAINE |
| 2020-11-09 | Impel Pharmaceuticals | Regulatory IMPEL NEUROPHARMA ANNOUNCES FDA SUBMISSION OF NEW DRUG APPLICATION FOR INP104 FOR THE ACUTE TREATMENT OF MIGRAINE impelpharma.com ↗
INP104 is the Company’s first therapeutic candidate to be submitted for U.S. regulatory review. |
| 2020-10-07 | Impel Pharmaceuticals | Results IMPEL NEUROPHARMA PRESENTS DATA FROM PIVOTAL PHASE 3 REGISTRATION STUDY OF INP104 FOR THE TREATMENT OF ACUTE MIGRAINE AT 2020 MIGRAINE TRUST VIRTUAL SYMPOSIUM impelpharma.com ↗
66.3% of Patients Reported Pain Relief Within Two Hours of Treatment with Rapid Uptake via the Upper Nasal Space Resulting in Onset of Relief as Early as 15 Minutes for Some Patients |
| 2020-09-30 | Satsuma Pharmaceuticals, Inc. | Results Satsuma Pharmaceuticals Announces Topline Results from EMERGE Phase 3 Trial of STS101 for the Acute Treatment of Migraine satsumarx.com ↗
Satsuma Pharmaceuticals, Inc. (Nasdaq: STSA), a clinical-stage biopharmaceutical company, today announced topline results from its Phase 3 EMERGE efficacy trial of STS101 (dihydroergotamine (DHE) nasal) powder as an acute treatment for migraine. |
| 2020-06-15 | Impel Pharmaceuticals | Results IMPEL NEUROPHARMA PRESENTS DATA FROM INP104 CLINICAL PROGRAM IN ACUTE MIGRAINE AT THE 2020 AMERICAN HEADACHE SOCIETY (AHS) VIRTUAL ANNUAL SCIENTIFIC MEETING impelpharma.com ↗
Results suggest that delivery of DHE to the upper nasal space may provide an effective, consistent, and well-tolerated alternative to acute oral and injectable treatments for migraine, while providing the reliable efficacy, speed, and potency of the long-established DHE molecule. |
| 2020-06-10 | Impel Pharmaceuticals | Results IMPEL NEUROPHARMA ANNOUNCES PRIMARY OBJECTIVES MET IN PIVOTAL PHASE 3 REGISTRATION STUDY OF INP104 FOR THE TREATMENT OF ACUTE MIGRAINE impelpharma.com ↗
Exploratory efficacy data in the FSS (n=354) observed that 66.3% of patients achieved pain relief and 38% of patients achieved pain freedom at two hours following their first dose of INP104. |
| 2020-01-30 | Satsuma Pharmaceuticals, Inc. | Results Satsuma Pharmaceuticals Announces Publication of STS101 Phase 1 Clinical Trial Results in HEADACHE: The Journal of Head and Face Pain satsumarx.com ↗
Study authors concluded that STS101 showed a favorable tolerability profile and resulted in DHE plasma concentrations comparable to IM DHE and exceeding Migranal. |
| 2019-11-20 | Impel Pharmaceuticals | Results Impel Neuropharma Announces Publication of Narrative Review in The Journal Headache Supporting Need For Novel Formulations Of Dihydroergotamine (DHE) In Addressing Acute Treatment of Migraine impelpharma.com ↗
Importantly, DHE offers rapid onset, durable effects and works at any point after migraine onset. |
| 2019-07-30 | Satsuma Pharmaceuticals, Inc. | Results Satsuma Pharmaceuticals Announces Presentation of STS101 (Dihydroergotamine Nasal Powder) Phase 1 Trial Results at American Headache Society’s Annual Scientific Meeting satsumarx.com ↗
In this first-in-human trial, STS101 demonstrated rapid DHE absorption with the minimum threshold concentration we estimate to be necessary for drug efficacy achieved on average within ten minutes, sustained drug plasma levels, low PK variability, and favorable safety and tolerability. |
| 2019-07-10 | Impel Pharmaceuticals | Results Impel NeuroPharma to Present Data from INP104 Clinical Program at the 61st Annual Scientific Meeting of the American Headache Society impelpharma.com ↗ |
| 2019-05-01 | Impel Pharmaceuticals | Results Impel NeuroPharma To Present Data Highlighting Late-Stage Central Nervous System Pipeline At 2019 American Academy Of Neurology Meeting impelpharma.com ↗
Safety, Tolerability and Comparative Bioavailability Data Support INP104, Impel’s Nasal Drug Candidate for Acute Migraine |
| 2019-02-28 | Satsuma Pharmaceuticals, Inc. | Results Satsuma Pharmaceuticals Provides Corporate Update and Prepares to Advance Lead Product Candidate, STS101, Into Phase 3 Efficacy Trial for Acute Migraine satsumarx.com ↗
In a recently completed Phase 1 clinical trial, STS101 demonstrated a highly differentiated PK profile. |
| 2018-06-22 | Impel Pharmaceuticals | Regulatory Impel NeuroPharma Announces FDA Clearance of IND for Pivotal Phase 3 Study of INP104 for Acute Treatment of Migraine impelpharma.com ↗
Impel NeuroPharma, a Seattle-based, privately-held biotechnology company focused on therapies for the treatment of central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has notified the Company that it may proceed with its clinical investigation of INP104, a novel, dihydroergotamine (DHE) product dosed via Impel’s proprietary Precision Olfactory Delivery, or POD®, intranasal delivery device for the treatment of acute migraine. |
| 2018-02-08 | Impel Pharmaceuticals | Results Impel NeuroPharma Announces Positive Results of Phase 1 Clinical Trial of INP104 for Treatment of Acute Migraine Headache impelpharma.com ↗
In addition to meeting the primary endpoint of bioavailability, INP104 was well tolerated. |
All press releases naming this drug 37 releases
Evidence & citations 22 cited values
Every value below carries the sentence it was read from. 27 sources stand behind the page.
| Field | Value | Cited 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 ↗ |
| Known as | 9,10-dihydroergotamine | ChEMBL registry synonym — accepted as the source's own label CHEMBL1732 ↗ |
| Known as | D.H.E | “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 202013“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 ↗ |
| 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 ↗ |
| 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 ↗ |
| 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 |
| 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 20201“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 ↗ |