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Drug ReportsDihydroergotamine
Dihydroergotamine
Dihydroergotamine, Embolex, Migranal, Trudhesa (dihydroergotamine) is a small molecule pharmaceutical. Dihydroergotamine was first approved as D.h.e. 45 on 1982-01-01. It is used to treat cluster headache, migraine disorders, orthostatic hypotension, postpartum hemorrhage, and xerostomia in the USA. The pharmaceutical is active against 5-hydroxytryptamine receptor 1D. In addition, it is known to target 5-hydroxytryptamine receptor 1B, 5-hydroxytryptamine receptor 1F, 5-hydroxytryptamine receptor 1E, 5-hydroxytryptamine receptor 7, and 5-hydroxytryptamine receptor 6.
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Commercial
Clinical
Drug
Target
Variants
Financial
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Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
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Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
stomatognathic diseasesD009057
nervous system diseasesD009422
urogenital diseasesD000091642
cardiovascular diseasesD002318
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Dihydroergotamine, Migranal, Trudhesa (discontinued: D.h.e. 45, Dihydroergotamine)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Dihydroergotamine mesylate
+
Heparin sodium
+
Lidocaine hydrochloride
Tradename
Company
Number
Date
Products
EMBOLEXNovartisN-018885 DISCN1984-11-30
2 products
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Dihydroergotamine mesylate
Tradename
Company
Number
Date
Products
MIGRANALBausch Health CompaniesN-020148 RX1997-12-08
1 products, RLD, RS
TRUDHESAImpel PharmaceuticalsN-213436 RX2021-09-02
1 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
dihydroergotamine mesylateANDA2024-12-26
dihydroergotamine mesylate nasalANDA2024-01-13
dromelateANDA2022-02-23
migranalNew Drug Application2022-09-01
trudhesaNew Drug Application2025-01-17
Agency Specific
FDA
EMA
Expiration
Code
DIHYDROERGOTAMINE MESYLATE, TRUDHESA, IMPEL PHARMS
2024-09-02NP
Patent Expiration
Patent
Expires
Flag
FDA Information
Dihydroergotamine Mesylate, Trudhesa, Impel Pharms
111854972039-01-04U-3218
112667992036-11-05DP
99191172033-03-17DPU-3218
109402782033-01-23DP
105072952032-12-25DP
95500362032-09-05DP
ATC Codes
N: Nervous system drugs
— N02: Analgesics
— N02C: Antimigraine preparations
— N02CA: Ergot alkaloids, antimigraine
— N02CA01: Dihydroergotamine
— N02CA51: Dihydroergotamine, combinations
HCPCS
Code
Description
J1110
Injection, dihydroergotamine mesylate, per 1 mg
Clinical
Clinical Trials
74 clinical trials
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Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Renal insufficiencyD051437—N1911———1
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameDihydroergotamine
INNdihydroergotamine
Description
Dihydroergotamine is ergotamine in which a single bond replaces the double bond between positions 9 and 10. A semisynthetic ergot alkaloid with weaker oxytocic and vasoconstrictor properties than ergotamine, it is used (as the methanesulfonic or tartaric acid salts) for the treatment of migraine and orthostatic hypotension. It has a role as a serotonergic agonist, a non-narcotic analgesic, a vasoconstrictor agent, a dopamine agonist and a sympatholytic agent. It is an ergot alkaloid and a semisynthetic derivative.
Classification
Small molecule
Drug classergot alkaloid deriviatives
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Structure (InChI/SMILES or Protein Sequence)
CN1C[C@H](C(=O)N[C@]2(C)O[C@@]3(O)[C@@H]4CCCN4C(=O)[C@H](Cc4ccccc4)N3C2=O)C[C@@H]2c3cccc4[nH]cc(c34)C[C@H]21
Identifiers
PDB—
CAS-ID511-12-6
RxCUI—
ChEMBL IDCHEMBL1732
ChEBI ID4562
PubChem CID10531
DrugBankDB00320
UNII ID436O5HM03C (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
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Estimated US medical usage
Dihydroergotamine
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 14,580 documents
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Safety
Black-box Warning
Black-box warning for: Dihydroergotamine mesylate, Dihydroergotamine mesylate nasal, Dromelate, Migranal, Trudhesa
Adverse Events
Top Adverse Reactions
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1,272 adverse events reported
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