Drugs / Elismetrep
last change 9 days ago re-read 9 days ago

Elismetrep

also known as MT 8554 · K-304

Small molecule targets TRPM8 via inhibition

Developed for
migraine disorder · diabetic polyneuropathy · premature menopause
Investigated by
Tanabe Pharma Corporation · Kallyope Inc. · Tanabe Pharma America, Inc.

Trials 14

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 16 trials
Phase 1 NCT03471130 Apr → Oct 2018 — Tanabe Pharma America, Inc. Completed No outcome recorded
Phase 1 NCT03381404 Dec 2017 → Jan 2018 — Tanabe Pharma America, Inc. Completed No outcome recorded
Phase 1 NCT02803268 Jun 2016 → Jan 2017 — Tanabe Pharma Corporation Completed No outcome recorded
Phase 1 NCT02675309 Feb → Mar 2016 — Tanabe Pharma Corporation Completed No outcome recorded
Phase 1 NCT02536209 Aug → Nov 2015 — Tanabe Pharma Corporation Completed No outcome recorded
Phase 1 NCT02429102 Apr → Nov 2015 — Tanabe Pharma Corporation Completed No outcome recorded
Phase 25 trials
Phase 2 NCT06848075 Mar → Aug 2025 migraine disorder Kallyope Inc. Completed No outcome recorded
Phase 2 NCT05123196 Nov 2021 → Nov 2022 diabetic polyneuropathy Tanabe Pharma Corporation Completed No outcome recorded
Phase 2 NCT03541200 Apr 2018 → Nov 2019 — Tanabe Pharma America, Inc. Completed No outcome recorded
Phase 2 NCT03291067 Oct 2017 → Oct 2018 premature menopause Tanabe Pharma America, Inc. Completed No outcome recorded
Phase 2 NCT03172598 Jul 2017 → Aug 2018 diabetic polyneuropathy Tanabe Pharma Corporation Completed No outcome recorded
Phase 33 trials
Phase 3 NCT07816367 Oct 2026 → Oct 2027 expected migraine disorder Kallyope Inc. Recruiting No outcome recorded
Phase 3 NCT07645924 Jul 2026 → Feb 2027 expected migraine disorder Kallyope Inc. Recruiting No outcome recorded
Phase 3 NCT07674654 Jul 2026 → Jun 2028 expected migraine disorder Kallyope Inc. Not yet recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 4

DateIssuerRelease
2026-06-04 Kallyope Inc. Results Kallyope Presents New Data on Novel TRPM8 Channel Blocker Elismetrep for the Acute Treatment for Migraine at the American Headache Society 68th Annual Scientific Meeting kallyope.com ↗
Today, the Company presented results from several clinical and preclinical studies that support the initiation of Phase 3 studies of elismetrep, a novel TRPM8 channel blocker.
2026-04-22 Kallyope Inc. Results Kallyope’s Phase 2b Study of Elismetrep, A Novel Approach for Treating Migraine, Presented at the American Academy of Neurology Annual Meeting kallyope.com ↗
Today, the Company presented results from a Phase 2b dose-ranging and proof of concept study of elismetrep, a novel TRPM8 channel blocker and the only agent known to be in late-stage development for the acute treatment of migraine.
2026-03-05 Kallyope Inc. Results Kallyope to Present Phase 2b Study Results for Elismetrep for the Acute Treatment of Migraine at the 2026 American Academy of Neurology Annual Meeting kallyope.com ↗
Data validate novel TRPM8 migraine-associated channel blocker (MACB) and demonstrate a clinical profile competitive with leading approved therapeutics for migraine
2025-12-08 Kallyope Inc. Results Kallyope Announces Positive Results from Phase 2b Study of Elismetrep for the Acute Treatment of Migraine kallyope.com ↗
In the study, elismetrep delivered a favorable clinical profile through its novel mechanism, supporting its potential as a new therapeutic option for the large number of patients who are suffering from the debilitating effects of migraine.

Evidence & citations 7 cited values

Every value below carries the sentence it was read from. 15 sources stand behind the page.

FieldValueCited text
Known as Elismetrep ClinicalTrials.gov intervention name — accepted as the source's own label NCT07645924 ↗
3

NCT07816367 ↗

NCT07674654 ↗

NCT06848075 ↗

Known as K-304 “A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study of Elismetrep (K-304) in the Treatment of Migraine” NCT06848075 ↗
1

“Elismetrep (K-304)” NCT07645924 ↗

Known as MT 8554 “This is a study to definitively assess the effects of MT 8554, adjusted for placebo, on the change of the QT interval corrected for heart rate (HR) using the Fridericia formula...” NCT03471130 ↗
10

NCT02536209 ↗

NCT03291067 ↗

NCT02675309 ↗

NCT02429102 ↗

NCT03381404 ↗

NCT03471130 ↗

NCT02803268 ↗

NCT03541200 ↗

NCT03172598 ↗

NCT05123196 ↗

Action Inhibit “Transient receptor potential cation channel subfamily M member 8 inhibitor” CHEMBL3682589 ↗
Modality Small molecule — CHEMBL3682589 ↗
Route Oral “MT-8554 1mg QD, oral, 12 weeks” NCT03291067 ↗
Target TRPM8 “Transient receptor potential cation channel subfamily M member 8 inhibitor” CHEMBL3682589 ↗