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
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
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Heparin sodium
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Lidocaine hydrochloride
Dihydroergotamine mesylate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| MIGRANAL | Bausch Health Companies | N-020148 RX | 1997-12-08 | 1 products, RLD, RS |
| TRUDHESA | Impel Pharmaceuticals | N-213436 RX | 2021-09-02 | 1 products, RLD, RS |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| dihydroergotamine mesylate | ANDA | 2024-10-11 |
| dihydroergotamine mesylate nasal | ANDA | 2024-01-13 |
| dromelate | ANDA | 2022-02-23 |
| migranal | New Drug Application | 2022-09-01 |
| trudhesa | New Drug Application | 2023-08-01 |
Indications
FDA
EMA
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Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
DIHYDROERGOTAMINE MESYLATE, TRUDHESA, IMPEL PHARMS | |||
| 2024-09-02 | NP | ||
HCPCS
Code | Description |
|---|---|
| J1110 | Injection, dihydroergotamine mesylate, per 1 mg |
Clinical
Clinical Trials
74 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Migraine disorders | D008881 | EFO_0003821 | G43 | 4 | 1 | 7 | 1 | 1 | 14 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cholangiocarcinoma | D018281 | — | C22.1 | — | 3 | 7 | — | 3 | 11 |
| Recurrence | D012008 | — | — | 2 | 2 | 1 | — | — | 5 |
| Carcinoma | D002277 | — | C80.0 | 2 | 2 | 1 | — | 1 | 5 |
| Migraine without aura | D020326 | EFO_0005296 | G43.0 | 2 | — | 3 | — | — | 5 |
| Migraine with aura | D020325 | EFO_0005295 | G43.1 | 2 | — | 3 | — | — | 5 |
| Barrett esophagus | D001471 | EFO_0000280 | K22.7 | — | 3 | 2 | — | 1 | 5 |
| Headache | D006261 | HP_0002315 | R51 | 2 | — | 2 | — | — | 4 |
| Esophageal neoplasms | D004938 | — | C15 | — | 2 | 1 | — | 1 | 4 |
| Bile duct neoplasms | D001650 | — | — | — | 2 | 3 | — | — | 4 |
| Central nervous system neoplasms | D016543 | — | — | 1 | — | 2 | — | — | 3 |
Show 11 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | 5 | 3 | — | — | 7 | 14 |
| Non-small-cell lung carcinoma | D002289 | — | — | 5 | 3 | — | — | 3 | 10 |
| Malignant mesothelioma | D000086002 | — | — | 1 | 3 | — | — | 1 | 5 |
| Mesothelioma | D008654 | — | C45 | 1 | 3 | — | — | 1 | 5 |
| Healthy volunteers/patients | — | — | — | 5 | 1 | — | — | — | 5 |
| Head and neck neoplasms | D006258 | — | — | 1 | 2 | — | — | 1 | 4 |
| Neoplasms | D009369 | — | C80 | 1 | 1 | — | — | 1 | 3 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 2 | 1 | — | — | — | 3 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 1 | 1 | — | — | — | 2 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | — | 1 | — | — | 1 | 2 |
Show 9 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pleural diseases | D010995 | — | — | 2 | — | — | — | — | 2 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | — | — | — | 1 | 2 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 1 | — | — | — | — | 1 |
| Pancreatic ductal carcinoma | D021441 | — | — | 1 | — | — | — | — | 1 |
| Acinar cell carcinoma | D018267 | — | — | 1 | — | — | — | — | 1 |
| Skin neoplasms | D012878 | EFO_0004198 | C44 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Squamous cell neoplasms | D018307 | — | — | — | — | — | — | 1 | 1 |
| Adenocarcinoma of lung | D000077192 | — | — | — | — | — | — | 1 | 1 |
| Cigarette smoking | D000073865 | — | — | — | — | — | — | 1 | 1 |
| Ureteral obstruction | D014517 | HP_0006000 | — | — | — | — | — | 1 | 1 |
| Hepatocellular carcinoma | D006528 | — | C22.0 | — | — | — | — | 1 | 1 |
| Obstructive jaundice | D041781 | EFO_1001068 | — | — | — | — | — | 1 | 1 |
| Jaundice | D007565 | HP_0000952 | R17 | — | — | — | — | 1 | 1 |
| Disease progression | D018450 | — | — | — | — | — | — | 1 | 1 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Dihydroergotamine |
| INN | dihydroergotamine |
| 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 class | ergot alkaloid deriviatives |
| Image (chem structure or protein) |  |
| 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-ID | 511-12-6 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1732 |
| ChEBI ID | 4562 |
| PubChem CID | 10531 |
| DrugBank | DB00320 |
| UNII ID | 436O5HM03C (ChemIDplus, GSRS) |
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Estimated US medical usage
Dihydroergotamine
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
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Additional graphs summarizing 14,177 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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3,038 adverse events reported
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