Last reviewed · How we verify
Migranal (DIHYDROERGOTAMINE)
Migranal (Dihydroergotamine) is a small molecule ergotamine derivative that targets the 5-hydroxytryptamine receptor 1D. It is used to treat cluster headache syndrome, migraine, and vascular headache. Originally developed by Valeant, it is now owned by Bausch and has been FDA-approved since 1946. Migranal is off-patent and has multiple generic manufacturers. Key safety considerations include its short half-life and low bioavailability.
At a glance
| Generic name | DIHYDROERGOTAMINE |
|---|---|
| Sponsor | Bausch Health |
| Drug class | Ergotamine Derivative |
| Target | D(3) dopamine receptor |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 1946 |
Approved indications
- Cluster headache syndrome
- Migraine
- Vascular headache
Boxed warnings
- WARNING: PERIPHERAL ISCHEMIA FOLLOWING COADMINISTRATION WITH POTENT CYP3A4 INHIBITORS Serious and/or life-threatening peripheral ischemia has been associated with the co-administration of dihydroergotamine with potent CYP3A4 inhibitors including protease inhibitors and macrolide antibiotics. Because CYP3A4 inhibition elevates the serum levels of dihydroergotamine, the risk for vasospasm leading to cerebral ischemia and/or ischemia of the extremities is increased. Hence, concomitant use of these medications is contraindicated. (See CONTRAINDICATIONS and WARNINGS )
Common side effects
- Nightmare
- Sedation
- Nephrolithiasis
- Neovascularisation
- Hyperhidrosis
- Paradoxical drug reaction
- Nausea
- Product used for unknown indication
- Extrapyramidal disorder
- Anuria
- Drug ineffective for unapproved indication
- Reversible cerebral vasoconstriction syndrome
Key clinical trials
- A Study Evaluating the Safety, Tolerability and Pharmacokinetics of ASY202 in Healthy Adults (PHASE1)
- Beating Lung Cancer in Ohio Protocol in Improving Survival in Patients With Stage IV Non-Small Cell Lung Cancer (NA)
- A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Assess STS101 in the Acute Treatment of Migraine (PHASE3)
- A Study to Evaluate the Safety of STS101 in the Acute Treatment of Migraine (PHASE3)
- A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate STS101 in the Acute Treatment of Migraine (PHASE3)
- A Study to Assess the Safety, Tolerability, and Pharmacokinetics of PUR3100 in Health Adults (PHASE1)
- A Study of the PK and Safety of Single Doses of STS101, DHE Injection and Nasal Spray in Healthy Subjects (PHASE1)
- A Research Study Examining Migranal and Skin Sensitivity in Subjects With Migraine (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |