Drugs / Lasmiditan
Lasmiditan
also known as
COL-144 · LTN · Lasmiditan hemisuccinate · LASMIDITAN SUCCINATE · LY-573144 · LY-683974 · Rayvow · Reyvow
Small molecule targets HTR1F via activation
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed migraine disorder 1 milestone | |||||
| Filed | US (FDA) | — | migraine disorder | 2018-11-14 | “submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for lasmiditan for the acute treatment of migraine” lilly.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved | EU (EMA) | Rayvow | — | 2022-08-17 | europa.eu ↗ |
| Approved | US (FDA) | REYVOW | — | 2019-10-11 | fda.gov ↗ |
Trials 32
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 122 trials · 1 met primary · 1 missed | ||||||
| Phase 1 | NCT04881747 | May → Jul 2021 | — | Eli Lilly and Company | Completed | Met primary |
| Phase 1 | NCT04749914 | Feb → Jul 2021 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT04081324 | Nov 2019 → Jun 2020 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT03937648 | Aug → Oct 2019 | — | IlDong Pharmaceutical Co Ltd | Unknown | No outcome recorded |
| Phase 1 | NCT03988088 | Jul 2019 → Jan 2020 | migraine disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT03579940 | Jun → Aug 2018 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT03459612 | Mar → Jun 2018 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT03406260 | Jan → Apr 2018 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT03310411 | Oct → Dec 2017 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT03308669 | Oct → Dec 2017 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT03286218 | Sep → Nov 2017 | substance abuse | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT03270644 | Aug → Nov 2017 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT03247790 | Aug 2017 → Jan 2018 | migraine disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT03252015 | Aug 2017 → Jan 2018 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT03182920 | Jun → Aug 2017 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT03040362 | Apr → May 2017 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT03009162 | Apr → Jun 2017 | migraine disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT03076970 | Mar → Apr 2017 | migraine disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT03040479 | Mar → Jul 2017 | migraine disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT03012334 | Jan → Jun 2017 | migraine disorder | Eli Lilly and Company | Completed | Missed primary |
| Phase 1 | NCT02233296 | Jan → Feb 2015 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT03465436 | Sep → Dec 2011 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 23 trials · 2 met primary | ||||||
| Phase 2 | NCT03962738 | May 2019 → Jun 2020 | migraine disorder | Eli Lilly and Company | Completed | Met primary |
| Phase 2 | NCT00883051 | Jul 2009 → Feb 2010 | migraine disorder | Eli Lilly and Company | Completed | Met primary |
| Phase 2 | NCT00384774 | Nov 2006 → Jun 2007 | migraine disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 37 trials · 3 met primary | ||||||
| Phase 3 | NCT04396574 | Jun 2020 → Dec 2025 | migraine disorder | Eli Lilly and Company | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT04396236 | Jun 2020 → Nov 2025 | migraine disorder | Eli Lilly and Company | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT04218162 | Mar → Oct 2020 | migraine disorder | IlDong Pharmaceutical Co Ltd | Completed | No outcome recorded |
| Phase 3 | NCT03670810 | Jun 2019 → Jun 2020 | migraine disorder | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT02605174 | May 2016 → Jun 2017 | migraine disorder | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT02565186 | Oct 2015 → Aug 2019 | migraine disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT02439320 | Apr 2015 → Jul 2016 | migraine disorder | Eli Lilly and Company | Completed | Met primary |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2021-06-03 | Eli Lilly and Company | Results Lilly Reveals Critical Barriers to Optimal Migraine Care and Insights From Novel Clinical and Patient-Centric Real-World Evidence, Supporting Lilly's Preventive and Acute Treatment Portfolio at AHS 2021 lilly.com ↗
people taking 100 mg and 200 mg doses of REYVOW® (lasmiditan) C-V had greater odds of early onset of efficacy compared to those taking Nurtec® (rimegepant) or UBRELVY® (ubrogepant). |
| 2020-12-22 | IlDong Pharmaceutical Co Ltd | Results 일동제약, 편두통 신약 ‘라스미디탄’ 가교3상 완료 ildong.com ↗
임상시험 결과, 투약 2시간 후 편두통 통증이 해소된 환자의 비율이 위약 대비 라스미디탄 50mg 투여군은 1.2배, 라스미디탄 100mg 투여군은 2.0배(오즈비, Odds ratio)로 나타나, 1차 목적을 달성하였다. |
| 2020-10-06 | Eli Lilly and Company | Results REYVOW® (lasmiditan) C-V Demonstrated Superior Pain Freedom At 2 Hours in At Least 2 of 3 Migraine Attacks in New Phase 3 Consistency of Effect Study lilly.com ↗
Moreover, in at least 2 out of 3 attacks, Eli Lilly and Company's (NYSE: LLY) REYVOW demonstrated superiority over placebo in pain relief at 2 hours. |
| 2020-09-11 | Eli Lilly and Company | Results REYVOW® (lasmiditan) C-V Demonstrated Pain Freedom from Migraine Attacks At 60 Minutes and Up to 48 Hours in New Phase 3 Study lilly.com ↗
We are delighted that REYVOW met all 18 patient-centric endpoints. |
| 2019-10-11 | Eli Lilly and Company | Regulatory Lilly's REYVOW™ (lasmiditan), The First and Only Medicine in a New Class of Acute Treatment for Migraine, Receives FDA Approval lilly.com ↗
Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved REYVOW™ (lasmiditan) an oral medication for the acute treatment of migraine, with or without aura, in adults. |
| 2019-05-08 | Eli Lilly and Company | Results AAN 2019: Two New Analyses of Lasmiditan Phase 3 Studies Measured Onset of Effect and the Effect of Lasmiditan in Patients with Prior Triptan Experience lilly.com ↗
These new analyses showed that lasmiditan may provide rapid relief from a migraine attack and may be an effective option for p |
| 2018-12-03 | IlDong Pharmaceutical Co Ltd | Regulatory 일라이 릴리, 편두통치료제 라스미디탄 FDA 승인 신청 ildong.com ↗
일라이 릴리는 지난달 14일, 미국 FDA에 NDA(New Drug Application)를 제출했다고 현지 보도자료를 통해 밝혔다. |
| 2018-11-14 | Eli Lilly and Company | Regulatory Lilly Submits New Drug Application to the FDA for Lasmiditan for Acute Treatment of Migraine, Receives Breakthrough Therapy Designation for Emgality™ (galcanezumab-gnlm) for Prevention of Episodic Cluster Headache lilly.com ↗
Eli Lilly and Company (NYSE: LLY) has announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for lasmiditan for the acute treatment of migraine with or without aura in adults. |
| 2017-09-09 | Eli Lilly and Company | Results IHC 2017: Lilly's Lasmiditan Significantly Reduces Pain in Patients with Migraine lilly.com ↗
At two hours following the first dose, a greater percentage of patients treated with lasmiditan were migraine pain-free compared to placebo. |
| 2017-08-04 | Eli Lilly and Company | Results Lilly Announces Positive Results for Second Phase 3 Study of Lasmiditan for the Acute Treatment of Migraine lilly.com ↗
Eli Lilly and Company (NYSE: LLY) announced today that lasmiditan, an investigational, oral, first-in-class molecule for the acute treatment of migraine, met its primary endpoint in SPARTAN, a second Phase 3 study. |
| 2016-09-08 | IlDong Pharmaceutical Co Ltd | Results 편두통치료신약 ‘라스미디탄’ 3상 1차 효능시험 결과발표 ildong.com ↗
콜루시드에 따르면, 라스미디탄의 임상3상 시험에서 유효성 평가 결과 편두통에 대한 치료효과를 성공적으로 입증하였으며, 안전성 평가결과 역시 위약(플라시보)과 비교해 큰 차이가 없었다. |
All press releases naming this drug 15 releases
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 37 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Lasmiditan | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03459612 ↗ |
| Known as | COL-144 | “Lasmiditan (COL-144) is a novel, centrally acting, highly selective” PMID 22459549 ↗ Mar 2012 |
| Known as | Lasmiditan hemisuccinate | ChEMBL registry synonym — accepted as the source's own label CHEMBL3039520 ↗ |
| Known as | LASMIDITAN SUCCINATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL3039520 ↗ |
| Known as | LTN | “To evaluate the efficacy of lasmiditan (LTN) in treating migraine attacks of mild vs. moderate or severe pain intensity.” PMID 33784930 ↗ Apr 20211“Lasmiditan (LTN) is a selective 5-HT1F receptor agonist for the acute treatment of migraine in adults.” PMID 34742230 ↗ Nov 2021 |
| Known as | LY-573144 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3039520 ↗ |
| Known as | LY-683974 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3039520 ↗ |
| Known as | Rayvow | ChEMBL registry synonym — accepted as the source's own label CHEMBL3039520 ↗ |
| Known as | Reyvow | ChEMBL registry synonym — accepted as the source's own label CHEMBL3039520 ↗ |
| Action | Activate | “Serotonin 1f (5-HT1f) receptor agonist” CHEMBL3039520 ↗1“potent agonist at 5-HT(1F) receptors” PMID 20855362 ↗ Jun 2010 |
| Modality | Small molecule | — CHEMBL3039520 ↗ |
| Route | Intravenous | “Administered as intravenous infusion” NCT00384774 ↗ |
| Target | HTR1F | “Serotonin 1f (5-HT1f) receptor agonist” CHEMBL3039520 ↗ |