Drugs / Diclofenac epolamine
Diclofenac epolamine
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | LICART | — | 2026-03-27 | fda.gov ↗ |
| Label expansion | US (FDA) | FLECTOR | — | 2019-03-01 | fda.gov ↗ |
| Approved | US (FDA) | FLECTOR | — | 2007-01-31 | fda.gov ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT01380353 | Jun 2011 → Nov 2012 | breast cancer | Northwestern University | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT05171673 | Oct 2021 → Jun 2024 | — | IBSA Institut Biochimique SA | Completed | No outcome recorded |
| Phase 3 | NCT02324270 | May → Dec 2014 | — | Actavis Inc. | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| — | NCT01263652 Comparator | Dec 2010 → Jun 2019 | — | Western Galilee Hospital-Nahariya | Withdrawn | No outcome recorded Stop: Enrollment |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Diclofenac epolamine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02324270 ↗ |
| Known as | Diclofenac hydroxyethylpyrrolidine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01263652 ↗ |
| Known as | Licart | “The Licart™ (diclofenac epolamine) topical system was designed to deliver the nonsteroidal anti-inflammatory drug (NSAID) diclofenac to the site of a minor soft tissue injury...” NCT05171673 ↗ |
| Route | Intramuscular | “IM/PO” NCT01263652 ↗ |
| Route | Oral | “IM/PO” NCT01263652 ↗ |