Ubrogepant
| Evidence Level: L5 | Predicted Indications: 2 |
Table of Contents
Ubrogepant: Atrophoderma vermiculata
One-Sentence Summary
Ubrogepant is an oral CGRP receptor antagonist (a “gepant”), originally used for the acute treatment of migraine with or without aura in adults. The TxGNN model predicts it may be effective for atrophoderma vermiculata. No clinical trials are registered for this subtype, but 18 publications on ubrogepant in general migraine populations provide indirect support.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Atrophoderma vermiculata |
| TxGNN Prediction Score | 0.9940 |
| Evidence Level | L5 |
| Canada Market Status | Marketed (marketed DINs: 2 of 2) |
| Number of DINs | 2 (marketed: 2) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available in the data compiled for this report. Based on the published literature, ubrogepant is a small-molecule, highly selective CGRP receptor antagonist. CGRP is a key mediator of pain signalling in the trigeminovascular system during migraine attacks.
Migraine with brainstem aura is a migraine subtype that shares this trigeminovascular and CGRP-mediated pathophysiology with the approved indication. The mechanistic rationale is therefore reasonable. Unlike triptans, gepants do not act through vasoconstriction, so that concern is not a barrier here.
However, the supplied literature covers general migraine populations and does not specifically enrol patients with brainstem aura. The evidence is indirect. The very high TxGNN score largely reflects proximity to the approved migraine indication rather than independent evidence.
Clinical Trial Evidence
Currently no related clinical trials registered for migraine with brainstem aura.
Literature Evidence
The 10 most relevant publications are listed below, prioritising RCTs and trials over reviews and case reports. None targets brainstem aura specifically.
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 37979595 | 2023 | RCT (Phase 3) | Lancet | Ubrogepant 100 mg vs placebo for treating migraine attacks during the prodrome |
| 39569702 | 2025 | Clinical trial (safety) | Headache | Safety and tolerability of ubrogepant in people taking atogepant for preventive treatment of episodic migraine (TANDEM study) |
| 35790906 | 2022 | Network meta-analysis | J Headache Pain | Relative efficacy of lasmiditan vs rimegepant and ubrogepant as acute migraine treatments |
| 31913519 | 2020 | Phase 3 extension | Headache | 52-week long-term safety and tolerability of ubrogepant for acute migraine |
| 33874756 | 2021 | Post hoc analysis of RCTs | Cephalalgia | Safety and efficacy of ubrogepant across cardiovascular risk categories (ACHIEVE I and II) |
| 33749826 | 2021 | Post hoc analysis | Headache | Ubrogepant efficacy based on prior triptan exposure and response |
| 33547676 | 2021 | Real-world study | Headache | Real-world efficacy, tolerability and safety in a tertiary headache centre |
| 31800988 | 2019 | Phase 3 trial report | N Engl J Med | Ubrogepant, an oral CGRP receptor antagonist, for acute migraine treatment |
| 32020557 | 2020 | Review | Drugs | Summary of development milestones leading to first approval for acute migraine (± aura) |
| 39262541 | 2024 | Case report | Cureus | Substantial improvement in a patient with treatment-resistant migraine without aura |
Canada Market Information
| DIN | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 02532581 | UBRELVY | Not specified | Not specified |
| 02532530 | UBRELVY | Not specified | Not specified |
Safety Considerations
Drug Interactions: 76 potential interactions were identified. Those rated Major include:
- Clarithromycin
- Cobicistat
- Lumacaftor
Moderate-level interactions include aprepitant, dexamethasone, cimetidine, eliglustat, eluxadoline, miconazole, clotrimazole, rolapitant, ticagrelor, eltrombopag and quinine, among others.
Please refer to the package insert for warnings and contraindications.
Conclusion and Next Steps
Decision: Hold
Rationale: The mechanistic link to the approved migraine indication is plausible, but there are no trials or publications specific to brainstem aura. The high TxGNN score mainly reflects similarity to the approved indication, so the evidence stays at L4 (indirect).
To proceed, the following is needed:
- Subgroup or post hoc analyses of existing ubrogepant trials for patients with brainstem aura
- Detailed mechanism of action data
- Health Canada package insert warnings and contraindications, to complete safety screening
- Approved indication text and dosage form for the Canadian DINs
- A dedicated study or registry in this subtype, if the clinical need is confirmed
Other predictions (not recommended for follow-up): Atrophoderma vermiculata (score 0.9940) and ulerythema ophryogenesis (score 0.9923) have no clinical trials, no literature and no clear mechanistic link to CGRP antagonism. Both remain at L5 (model prediction only) and are on Hold.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.