Migraine is the third most prevalent disease and the leading reason of years lived with disability in the most productive years of the life. Migraine associated disability can be alleviated by acute and preventive treatment. The migraine landscape has changed recently, with the approval of novel acute treatments, including oral Calcitonin gene-related peptide antagonists, the gepants (Rimegepant, Ubrogepant, Zavegepant) and 5-HT-1F antagonists, the Ditans (Lasmiditan). These have joined Triptans as acute "migraine-specific" drugs.
The TRIDIGEP study will be an open-label, multiple attack, prospective cohort study.
This study aims to describe 1) the effectiveness of the acute treatments of migraine attacks in routine clinical practice, 2) the tolerability of the drugs, and 3) to explore potential response and tolerability predictors.
The endpoints recommended by the International Headache Society will be employed, including: 1) Pain freedom; 2) Absence of the most bothersome symptom; 3) Sustained pain freedom; 4) Total freedom from migraine; 5) Headache relief; 6) Duration of attacks; 7) Time lost due to an attack; 8) Need of rescue medication. The study endpoints will be assessed at 2, 8 and 24 hours after the acute drug use. Data will be collected by the patients themselves, with a validated data collection instrument within a RedCap questionnaire, using QR codes.

Start Date04 Dec 2023

Sponsor / Collaborator

Hospital Clínico Universitario de Valladolid

CTR20233131

/ RecruitingNot Applicable

拉米地坦片人体生物等效性研究预试验

[Translation] Preliminary study on bioequivalence of lamiditan tablets in humans

主要研究目的：以江苏恩华药业股份有限公司研制生产的拉米地坦片（规格：100 mg）为受试制剂，以礼来制药研发生产的拉米地坦片（Reyvow®，规格：100 mg）为参比制剂，研究在中国健康成年受试者单次空腹/餐后口服两制剂的吸收速度和吸收程度，初步评价两制剂间的生物等效性，为后期正式生物等效性试验方案的采血点、清洗期、例数等设计提供依据。次要研究目的：评估健康受试者单次空腹/餐后口服拉米地坦片受试制剂和参比制剂后的安全性。

[Translation]

The main purpose of the study is to use the Lamiditan tablets (specification: 100 mg) developed and produced by Jiangsu Enhua Pharmaceutical Co., Ltd. as the test preparation and the Lamiditan tablets (Reyvow®, specification: 100 mg) developed and produced by Eli Lilly and Company as the reference preparation to study the absorption rate and extent of the two preparations after a single fasting/postprandial oral administration in healthy adult subjects in China, preliminarily evaluate the bioequivalence between the two preparations, and provide a basis for the design of blood sampling points, washout period, number of cases, etc. of the formal bioequivalence test plan in the later stage. Secondary purpose of the study: To evaluate the safety of the test preparation and reference preparation of Lamiditan tablets after a single fasting/postprandial oral administration in healthy subjects.

Start Date02 Nov 2023

Sponsor / Collaborator

Jiangsu Nhwa Pharmaceutical Co., Ltd.

NCT05903040

/ CompletedNot ApplicableIIT

Effectiveness and Tolerability of Lasmiditan as Acute Migraine Treatment: a Prospective, Multicentric, Cohort Study

The purpose of this prospective and multicentric study is to evaluate the effectiveness and tolerability of lasmiditan as acute migraine treatment in a cohort of episodic or chronic migraine patients.

Start Date15 Jun 2023

Sponsor / Collaborator

University of Florence

[+6]

100 Clinical Results associated with Lasmiditan Succinate

100 Translational Medicine associated with Lasmiditan Succinate

100 Patents (Medical) associated with Lasmiditan Succinate

203

Literatures (Medical) associated with Lasmiditan Succinate

01 May 2026·EUROPEAN JOURNAL OF MEDICINAL CHEMISTRY

From structural evolution to an AI-driven future of 5-HT1F receptor agonists for migraine therapy

Review

Author: He, Shan ; Jin, Haixiao ; Wang, Tingting ; Zhang, Dashuai ; Cao, Yahui ; Wu, Jiale ; Lin, Lu

Migraine is a prevalent and disabling neurological disorder that imposes a substantial global disease burden, particularly among women of childbearing age. Although therapies targeting the calcitonin gene-related peptide (CGRP) pathway have improved migraine management, a considerable proportion of patients exhibit an insufficient clinical response, highlighting the importance of CGRP-independent mechanisms. The 5-hydroxytryptamine 1F (5-HT_1F) receptor, expressed in trigeminal neurons and involved in trigeminovascular signaling without vasoconstriction, represents a promising therapeutic target. The clinical approval of lasmiditan has validated the therapeutic potential of 5-HT_1F agonism, although its association with central nervous system adverse effects underscores the need for safer and more selective ligands. This review integrates current understanding of the role of 5-HT_1F receptor in migraine and systematically traces the structural evolution of small-molecule agonists, from early indole-based scaffolds through to simplified and clinically relevant chemotypes, while emphasizing conserved pharmacophoric features and geometric determinants of selectivity. We further discuss how artificial intelligence (AI)-driven approaches, including structure-aware generative modeling and knowledge-guided design, offer a strategic pathway to address the ligand-scarcity challenge of this low-data GPCR, potentially accelerating the discovery of next-generation 5-HT_1F receptor agonists with optimized safety and efficacy. Collectively, this work links biological insight, medicinal chemistry evolution, and emerging computational tools to inform the development of improved antimigraine therapies.

01 Apr 2026·JOURNAL OF CHROMATOGRAPHIC SCIENCE

Analytical quality by design (AQbD)-assisted bioanalytical method for the estimation of Lasmiditan in human plasma by reverse phase–high performance liquid chromatography (RP-HPLC)

Article

Author: Kishore, Pasupuleti ; Kuppusamy, Sujatha ; Azhakesan, Ajitha ; Sparsha, Burugula

Abstract:

Migraine is a complex neurological condition that often involves a severe headache characterized by moderate to severe throbbing. Lasmiditan a novel ditan approved by USFDA in 2011 to treat migraine. This contemporary research elaborates the systematic development and validation of Reverse Phase-High Performance Liquid Chromatography bio analytical method for estimating Lasmiditan in human plasma employing analytical quality by design. Bio analysis employing protein precipitation was performed to extract Lasmiditan from human plasma using Dolutegravir as the internal standard. Design of Experiments was incorporated employing central composite design, and the methodology was assessed for critical analytical attributes by varying the critical quality attributes using Design Expert Software Version 13.0. The chromatographic conditions optimized were symmetry C18 (150 × 4.6 mm, 5 μ) column, mobile phase 0.1% orthophosphoric acid: acetonitrile (70:30 (v/v) with a flow rate of 1.0 mL/min at detection wavelength of 260 nm and column temperature of 30°C. Validation studies indicated linearity between 20 and 800 ng/mL (r2 = 0.999), whereas accuracy and precision portrayed a 98.79% recovery. Succinctly, current work exemplifies the significant merits of analytical quality by design approach toward the holistic process in bioanalytical method validation. Furthermore, the method was evaluated using the Whiteness Assessment Tool (Blue Applicability Grade Index), yielding a high score of 82.5, indicating superior performance in terms of analytical efficiency, environmental friendliness and operator safety. Thus, the developed method can be applied for estimation of preclinical and clinical samples of Lasmiditan with improved accuracy and precision.

16 Mar 2026·Expert Review of Pharmacoeconomics & Outcomes Research

Cost of rimegepant and lasmiditan associated adverse events, for acute treatment in migraine in Spain

Review

Author: Rubio-Terrés, Carlos ; Rubio-Rodríguez, Darío ; Moya-Alarcón, Carlota ; Armada, Beatriz ; Santos-Lasaosa, Sonia ; Irimia, Pablo

OBJECTIVE:

To compare the cost of adverse events (AEs) associated with the acute treatment with rimegepant (RIM) versus lasmiditan (LAS) for migraine in Spain.

METHODS:

A probabilistic modeling analysis was performed, using second-order Monte Carlo simulations, from the perspective of the Spanish National Health System (SNHS). The cost per patient of all AEs described with RIM or LAS in 12 clinical trials, obtained through a systematic review, was analyzed. Several sensitivity analyzes (among them, a matching adjusted indirect comparison -MAIC- of the two long-term studies) were also performed. The cost of AEs management (€ 2024) was obtained from Spanish sources.

RESULTS:

The probabilistic model estimated that RIM compared to LAS would generate savings of €612.79 (95% CI €159.49-1339.43) per treated patient with migraine, in a treatment period of 6.11 ± 3.25 months, €98.54 per month. In the MAIC analysis, a saving per patient of €697.04 (95% CI: €514.44-879.04) was obtained in a treatment period of 12.4 months. The probability of RIM saving in all analysis was 100%.

CONCLUSIONS:

In accordance with this model, the favorable safety profile of RIM compared to LAS would generate savings for the SNHS in health-care resources in all the scenarios considered.

News (Medical) associated with Lasmiditan Succinate

13 May 2026

·www.biospace.com

Anaveon Appoints Thomas P. Mathers as Chair of the Board of Directors

Thomas P. Mathers Anaveon appoints Thomas P. Mathers as Chair of the Board of Directors. BASEL, Switzerland, May 13, 2026 (GLOBE NEWSWIRE) -- Anaveon, a late-stage biotechnology company pioneering precision biologics to reprogram the immune system for the treatment of autoimmune and inflammatory diseases, today announced the appointment of Thomas P. Mathers as Chair of its Board of Directors. His appointment will be confirmed in the upcoming Annual General Meeting in June. Dieter Weinand, who served as Chair since 2024, has stepped down from the Board. Mr. Mathers brings over 32 years of distinguished executive leadership in the life sciences sector, with a proven track record in company building, capital raising, public market transitions, and strategic value creation. As a Partner at Pappas Capital and Executive Chairman of Aer Therapeutics, he is widely recognized for his expertise in advancing innovative therapies from discovery through commercialization. “We are thrilled to welcome Tom as Chair of Anaveon’s Board at this pivotal moment,” said Thaminda Ramanayake, Chief Executive Officer of Anaveon . “His exceptional experience in scaling biotechnology companies, securing substantial financing, and navigating complex regulatory and commercial landscapes will be invaluable as we advance our lead immunology programs into clinical development and expand our pipeline of novel drug candidates. We are deeply grateful to Dieter Weinand for his dedicated service and strategic guidance during a critical foundational period and wish him continued success.” “I am honored to join Anaveon as Chair of the Board,” said Thomas P. Mathers. “The company’s innovative approach to selectively modulating immune pathways has tremendous potential to deliver transformative therapies for patients with significant unmet needs in autoimmune diseases. I look forward to partnering with Thaminda, the executive team, and the Board to accelerate growth, strengthen strategic execution, and realize Anaveon’s vision of reshaping immune-mediated disease treatment.” Leadership in Action: Thomas P. Mathers’ Track Record Mr. Mathers currently serves as Executive Chairman (and Interim CEO) of Aer Therapeutics, developing novel therapies for serious airway diseases, and as Vice Chairman of Certa Therapeutics, focused on fibrosis treatments. He is also Treasurer and a member of the Executive Committee of the Biotechnology Innovation Organization (BIO), where he actively shapes advocacy, regulatory policy, capital formation, bioethics, and intellectual property initiatives. He additionally serves on the U.S. Department of Veterans Affairs Research Advisory Committee on Gulf War Veterans’ Illnesses. In 2019, he founded Allievex Corp., a clinical-stage company developing therapies for neuronopathic lysosomal storage diseases such as Sanfilippo Syndrome. He led the company as President, CEO, and Director until its acquisition by Spruce Biosciences in 2024. Previously, as President and CEO of CoLucid Pharmaceuticals (NASDAQ: CLCD), he advanced lasmiditan for acute migraine treatment through key development milestones, culminating in its acquisition by Eli Lilly in 2017 for nearly $1 billion. Earlier in his career, Mr. Mathers held senior leadership roles at Peptimmune, Cell Based Delivery, Cardion AG, and Genzyme Corporation. He holds a B.S. in Engineering from the United States Military Academy at West Point (1988), where he played varsity football. He served as a Captain and AH-64 Apache helicopter pilot in the U.S. Army during the Gulf War, earning multiple military honors. ENDS Media contact: Benz Advisory Beatrix Benz Email: beatrix.benz@anaveon.com Tel: +41 79 256 77 73 About Anaveon: Anaveon AG is a late-stage preclinical biotechnology company headquartered in Basel, Switzerland focused on developing next-generation precision biologics that target central regulatory nodes of the immune system. The company’s engineered antibodies and cytokine-based therapies aim to selectively eliminate or reprogram pathogenic immune cells, restoring durable immune balance in autoimmune and inflammatory diseases. For more information, visit > anaveon.com A photo accompanying this announcement is available at

Executive ChangeAcquisition

19 Sep 2024

·www.fiercepharma.com

New migraine drugs less effective than previous generation of triptan meds: BMJ study

A meta-analysis of 137 trials of migraine drugs indicates that the newest class of treatments are less effective than the previous generation of triptan drugs in relieving acute headaches. A study from The BMJ indicates that the newest class of migraine drugs—which includes Pfizer’s Nurtec, AbbVie’s Ubrelvy and Eli Lilly’s Reyvow—is less effective in the acute treatment of migraines than a previous class of medicines.What's more, the newer drugs are no more effective in treating migraines than traditional headache remedies such as Tylenol, ibubrofen and aspirin, according to The BMJ's analysis.The study, a meta-analysis of 137 trials that together enrolled nearly 90,000 patients, indicates that the most effective treatments for migraine come from the triptan class. In head-to-head comparisons of the 17 drugs covered in the study, triptans demonstrated the best efficacy within 2 hours of use, led by eletriptan, which also delivered the best-sustained relief over 24 and 48 hours, according to the analysis.Eletriptan was brought to the market by Pfizer in 2002 and sold under the brand name Relpax. The next most effective medicines in providing relief at 2 hours were the following triptans (in order of performance): rizatriptan, sumatriptan and zolmitriptan. Rizatriptan is sold by Organon as Maxalt. GSK sells sumatriptan as Imitrex and AstraZeneca markets zolmitriptan as Zomig.“Triptans are currently widely underused, and access to the most effective triptans should be promoted globally and international guidelines updated accordingly,” the authors wrote. The BMJ analysis also concluded that the newest class of migraine treatments—which are called calcitonin gene-related peptide receptor (CGRP) antagonists—should only be used after traditional headache meds.“While the recent introduction of lasmiditan (Reyvow), rimegepant (Nurtec), and ubrogepant (Ubrelvy) has expanded options for the acute treatment of migraine, the high cost of these newer drugs, along with the substantial adverse effects of lasmiditan, suggest their use as third-line options, after the less expensive, similarly efficacious, second-line options," the authors wrote.While the BMJ study focused on acute treatment of migraines, new CGRP treatments have also been approved as preventatives. Nurtec pills, for example, were approved in 2021 for use every other day to ward off potential migraines. Much hope has been pinned on the effectiveness of CGRP drugs. In 2022, Pfizer spent $11.6 billion in a buyout of Biohaven to gain Nurtec, which rolled up sales of $928 million last year. Meanwhile, Ubrelvy, which was approved in 2019, generated $815 million in sales.Several other CGRPs—all approved in 2018 for the prevention of migraines—also remain formidable. Eli Lilly’s Emgality generated $678 million in sales last year, while Teva’s Ajovy pulled in $435 million and Amgen’s Aimovig collected $303 million. Besides those drugs, Lundbeck's Vyepti won approval in 2020 and generated about $250 million last year.

Drug ApprovalAcquisitionClinical Result

19 Sep 2024

·pharma.economictimes.indiatimes.com

Triptan drugs found to be more effective against migraines than newer ones

New Delhi: Triptan class of drugs are more effective in treating migraine headaches, compared to newer and more expensive drugs, an analysis of nearly 140 clinical trials , involving about 90,000 participants, has suggested. The analysis, published in The British Medical Journal , showed that eletriptan, rizatriptan, sumatriptan, and zolmitriptan were better in relieving pain than the relatively recently developed drugs -- lasmiditan, rimegepant, and ubrogepant. All these drugs are marketed in India. Commercially available since the 1990s, triptan drugs work by changing how blood is circulated in brain and by silencing overactive pain nerves, they change how pain is processed. While numerous antimigraine drugs are available, researchers, including those from Copenhagen University Hospital in Denmark, said that there is clear consensus as to which performs best in treating the neurological condition affecting more than a billion around the world. It is also the leading cause of disability or poor health in girls and women aged 15-49 years. The researchers said that triptans are widely underused and added that they should be "considered the treatment of choice for migraine episodes, owing to their capacity for inducing rapid and sustained pain freedom." While some of the triptan class of drugs have been studied to lower menstrual migraines too, which can be more severe and last longer than non-menstrual migraines, women should be cautious and avoid overuse, according to the American Migraine Foundation . The authors called for an improved access to triptan drugs worldwide by including them into the WHO Model List of Essential Medicines, along with updating international clinical guidelines for diagnosing and managing migraines. For the study, the researchers identified a total of 137 randomised controlled trials, published up to June 24, 2023, and comprising 89,445 participants -- who were aged 40 years on average and 86 per cent of whom were women. "When the active interventions (drugs) were compared with each other, eletriptan was superior to almost all the other drugs for achieving pain freedom at two hours, followed by rizatriptan, sumatriptan, and zolmitriptan," the authors wrote. Further, among the triptan drugs, eletriptan was found to be the most effective in bringing about a sustained freedom from pain for up to 24 hours. The researchers said that the results "offer the best available evidence to guide the choice of acute oral drug interventions for migraine episodes."

Clinical Result

100 Deals associated with Lasmiditan Succinate

External Link

KEGG	Wiki	ATC	Drug Bank
D10424	Lasmiditan Succinate	N02C	DB11732

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Migraine Disorders	United States	Eli Lilly & Co.	11 Oct 2019

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Migraine Without Aura	Phase 3	United States	Eli Lilly & Co.	24 Jun 2019
Migraine Without Aura	Phase 3	China	Eli Lilly & Co.	24 Jun 2019
Migraine Without Aura	Phase 3	Austria	Eli Lilly & Co.	24 Jun 2019
Migraine Without Aura	Phase 3	Belgium	Eli Lilly & Co.	24 Jun 2019
Migraine Without Aura	Phase 3	Czechia	Eli Lilly & Co.	24 Jun 2019
Migraine Without Aura	Phase 3	Denmark	Eli Lilly & Co.	24 Jun 2019
Migraine Without Aura	Phase 3	France	Eli Lilly & Co.	24 Jun 2019
Migraine Without Aura	Phase 3	Germany	Eli Lilly & Co.	24 Jun 2019
Migraine Without Aura	Phase 3	Hungary	Eli Lilly & Co.	24 Jun 2019
Migraine Without Aura	Phase 3	India	Eli Lilly & Co.	24 Jun 2019

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05903040 (DART, Pubmed \| Ther Adv Neurol Disord)	Not Applicable	Migraine Disorders	58	Lasmiditan 50 or 100 mg	hubztvbecf(kenyyxfeik) = wgksufgznp jiwitnanlf (mcpdzgeyjy ) View more	Positive	01 Jan 2025
NCT05903040 (DART, EAN2024)	Not Applicable	Acute migraine	55	Lasmiditan 50mg	ttqshudydm(bzneycomso) = Adverse events were reported in 53.1% of attacks, predominantly as dizziness ( n = 11), fatigue ( n = 8) and paraesthesia ( n = 6) irzkybccbj (mwtfdvhlpm )	Positive	28 Jun 2024
				Lasmiditan 100mg
NCT04749914 (CTgov)	Phase 1	-	97	Dabigatran Etexilate (150 mg Dabigatran Etexilate (Part 1 Period 1))	iaysectlxx(arjcccndch) = xpzyfhcxnq sztjzkvvcq (xnfwwtretp, 55) View more	-	01 Feb 2024
				Lasmiditan+Dabigatran Etexilate (150 mg Dabigatran Etexilate + 200 mg Lasmiditan (Part 1 Period 2))	iaysectlxx(arjcccndch) = wurstkaidp sztjzkvvcq (xnfwwtretp, 51) View more
NCT04881747 (CTgov)	Phase 1	Migraine Disorders	47	Lasmiditan	ydwieazyvc(zrmjbhremq) = idvaoxmykx wixawqqghv (flflizfdhm, 43) View more	-	23 Mar 2023
NCT03962738 (MONONOFU, Pubmed)	Phase 2	Migraine Disorders	846	Lasmiditan 50 mg	bqqcuqikwk(kppzkbolbg) = irypcxglmj sapxqmdddz (fpceenuwra )	Positive	22 Sep 2022
				Lasmiditan 100 mg	nkrmkebkcb(pyicbfejep) = prvthtudqo zvxowfoogh (iglawytsgy ) View more
NCT03670810 (CENTURION, Pubmed)	Phase 3	Migraine Disorders	281	Lasmiditan 200 mg	vyrfejksfe(aepuxmuzpr) = no study drug-related treatment emergent serious adverse events (TESAEs) were reported roubcvucxp (jupqotmvcy ) View more	Positive	17 Sep 2022
				Lasmiditan 100 mg
NCT02439320 \| NCT02605174 \| NCT03962738 \| NCT03670810 (Pubmed \| CNS Drugs)	Phase 2/3	Migraine Disorders	-	Lasmiditan 200 mg	vqmesvcrcv(togloqjuoa) = A common TEAE (CTEAE) was defined as occurring in ≥ 2% in the overall population. Central nervous system (CNS)-CTEAEs were based on Medical Dictionary for Regulatory Activities. lzplutmqpl (vyvmdtfbtc ) View more	-	02 Jul 2022
				Placebo
NCT03962738 (MONONOFU, Pubmed) Manual	Phase 2	Migraine Disorders	846	Lasmiditan	qzlcrlvnqb(odeduvxdke) = nxjfizmdrs deaulppiwe (hnktyoqnqa )	Positive	24 Jun 2022
				Placebo	qzlcrlvnqb(odeduvxdke) = kilbbsywje deaulppiwe (hnktyoqnqa )
NCT02565186 \| NCT02439320 \| NCT02605174 (SPARTAN, Pubmed \| Clin Ther)	Phase 3	Migraine Disorders	3,177	Lasmiditan	upasejjekj(eduvorbvkx) = Cardiovascular events were not reported in the elderly population during the treatment-emergent period or intermediate period zcyaycllcb (fodxtlifxo ) View more	-	06 Aug 2021
				Placebo
NCT03670810 (CENTURION, CTgov)	Phase 3	Migraine Disorders \| Migraine Without Aura	1,633	Placebo+Lasmiditan (200 mg Lasmiditan)	ttqxlhrfbo = uszcafqbxp asdineigbb (nxrkcusemr, cocyumdjlc - wfbqliipyy) View more	-	02 Jul 2021
				Placebo+Lasmiditan (100 Milligram (mg) Lasmiditan)	fjrvxvlqlt(qlkzbdcvka) = wyaxonlvmy mvegsoqamv (bxzzwivvdw, vqjhmdmtye - povpohtcvo) View more

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