Dexketoprofen
| Evidence Level: L1 | Predicted Indications: 10 |
Table of Contents
Dexketoprofen: From Acute Pain (NSAID) to Migraine Disorder
One-Sentence Summary
Dexketoprofen is a propionic-acid-derivative NSAID whose established use is short-term relief of acute mild-to-moderate pain; it currently holds no UK marketing authorisation in this dataset. The TxGNN model predicts it may be effective for Migraine Disorder, with 8 clinical trials and 20 publications currently supporting this direction — the strongest evidence base among all indications predicted for this drug.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Acute mild-to-moderate pain (NSAID analgesic) — no jurisdiction-specific licence text available |
| Predicted New Indication | Migraine disorder |
| TxGNN Prediction Score | 99.87% |
| Evidence Level | L1 |
| UK Market Status | Not marketed |
| Number of Marketing Authorisations | 0 |
| Recommended Decision | Proceed with Guardrails |
Why is This Prediction Reasonable?
Detailed mechanism-of-action data for this candidate is currently a data gap. Based on known pharmacology, dexketoprofen is the pharmacologically active S(+)-enantiomer of ketoprofen, a propionic-acid-class NSAID that non-selectively inhibits COX-1/COX-2, reducing prostaglandin synthesis and thereby peripheral and central pain sensitisation.
Its original use — acute mild-to-moderate pain — and the predicted new indication, migraine, share a common pharmacological pathway: NSAID-mediated COX inhibition reduces prostaglandin-driven activation and sensitisation of the trigeminovascular system, which underlies migraine pain. This is a well-established drug-class extension rather than a novel mechanistic hypothesis, and is corroborated by two closely related predictions for this candidate — headache disorder (rank 7, also L1/S3, “Proceed with Guardrails”) and migraine with brainstem aura (rank 8, L2/S2), which extend the same rationale to a broader headache population and to a specific migraine subtype respectively.
By contrast, several other TxGNN-predicted indications for dexketoprofen (tendinitis, rheumatoid arthritis, fibromyalgia, idiopathic granulomatous myositis, myositis fibrosa, exostosis, congenital hypotrichosis milia) carry weak-to-absent mechanistic or empirical support (evidence levels L3–L5, recommendation “Research Question” or “Hold”) and are not pursued further in this report.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrolment | Key Findings |
|---|---|---|---|---|
| NCT01730326 | Phase 4 | Completed | 200 | IV dexketoprofen vs IV paracetamol for acute migraine attack headache in the emergency department (direct head-to-head comparison) |
| NCT02159547 | Phase 4 | Completed | 224 | IV dexketoprofen vs placebo for acute migraine attack in the ED — largest placebo-controlled dataset for this indication |
| NCT04252521 | Phase 4/NA | Completed | 150 | IV metoclopramide vs dexketoprofen vs combination for acute migraine attack in the ED |
| NCT04372264 | Phase 4 | Unknown | 210 | Three-arm comparison of IV paracetamol, dexketoprofen and ibuprofen (VAS outcome) for acute migraine; design relevant but completion status unclear |
| NCT04533568 | Phase 4 | Completed | 160 | IV ibuprofen vs IV dexketoprofen for migraine-related headache in the ED (active-comparator design) |
| NCT05780671 | N/A | Completed | 160 | Dexketoprofen 50 mg + metoclopramide used as standard background therapy while testing supplemental oxygen; dexketoprofen not the primary intervention |
| NCT04519346 | NA | Completed | 150 | Intradermal mesotherapy vs systemic therapy (including NSAID) for migraine without aura; dexketoprofen not the sole focus |
| NCT06061588 | NA | Completed | 140 | Virtual reality technology for migraine-type headache; non-pharmacological comparator, included for population overlap only |
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 31725614 | 2019 | Meta-analysis (RCTs) | Medicine | Meta-analysis of RCTs assessing dexketoprofen vs placebo for migraine attack pain control |
| 25944813 | 2016 | RCT | Cephalalgia | Placebo-controlled RCT confirming efficacy of IV dexketoprofen in aborting migraine attacks in the ED |
| 24394884 | 2014 | RCT | Emergency Medicine Journal | RCT comparing IV dexketoprofen with paracetamol for acute migraine attack |
| 32359776 | 2020 | RCT | American Journal of Emergency Medicine | RCT of metoclopramide vs dexketoprofen vs combination for acute migraine attack |
| 24412801 | 2014 | RCT (Phase II) | The Journal of Pain | Dose-optimisation, placebo-controlled crossover RCT of dexketoprofen (25 mg/50 mg) for migraine |
| 25056381 | 2014 | RCT | Expert Review of Neurotherapeutics | Efficacy and tolerability of frovatriptan plus dexketoprofen combination for acute migraine |
| 41321235 | 2026 | Guideline | Headache | 2025 American Headache Society guideline update on parenteral pharmacotherapies (incl. NSAIDs) for ED migraine treatment |
| 24867846 | 2014 | RCT | Neurological Sciences | Early vs late dexketoprofen + frovatriptan combination vs frovatriptan alone for migraine attacks |
| 24363238 | 2014 | RCT | Cephalalgia | Frovatriptan + dexketoprofen combination superior to frovatriptan alone for migraine attacks |
| 11155464 | 2000 | Early clinical study | Minerva Medica | Early efficacy and safety evaluation of dexketoprofen trometamol in acute migraine attack |
UK Market Information
Dexketoprofen currently holds no UK marketing authorisation and no licences are recorded in this dataset (market status: Not marketed; 0 marketing authorisations on file). No BNF entry or NICE appraisal is applicable at this time.
Safety Considerations
Please refer to the SmPC and BNF for safety information. Report suspected adverse reactions via the Yellow Card Scheme.
Note: local product warnings/contraindications data (TFDA equivalent) is flagged as a Blocking data gap in this evidence pack — see Next Steps below.
Conclusion and Next Steps
Decision: Proceed with Guardrails
Rationale: Multiple completed Phase 4 RCTs (including a placebo-controlled trial, n=224) and a supportive meta-analysis consistently show dexketoprofen is effective for acute migraine attack pain, and this is reinforced by parallel evidence for the closely related “headache disorder” indication. However, all identified trials are Phase 4 (post-marketing) studies conducted outside the UK, and drug-level safety/regulatory data for this jurisdiction remain unresolved.
To proceed, the following is needed:
- Local product label data (warnings and contraindications) — currently a Blocking data gap preventing initial safety assessment (S1)
- Detailed mechanism-of-action confirmation via DrugBank — currently a High-severity data gap
- A drug-drug interaction review, as none is currently on file
- Confirmation of route/formulation compatibility (IV formulation used in cited trials) against any future UK licensing pathway
- Given the absence of a current UK marketing authorisation, a regulatory pathway assessment (e.g. licensing route) would be required before clinical evaluation can advance
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.