This is a non-interventional, prospective study that will enroll participants with migraine in the United Kingdom currently in use of rimegepant to acutely treat migraine attacks. Participants will be followed up for up to 12 weeks and will complete a daily questionnaire to self-report the consistency of response to rimegepant in acute treatment of migraine.

Start Date15 Nov 2025

Sponsor / Collaborator

Pfizer Inc.

CTR20253682

/ CompletedNot Applicable

硫酸瑞美吉泮口崩片（75mg）在中国健康研究参与者中空腹和餐后给药条件下随机、开放、单剂量、两序列、四周期、完全重复交叉生物等效性试验

[Translation] A randomized, open-label, single-dose, two-sequence, four-period, fully replicated crossover bioequivalence study of remedipam sulfate orally disintegrating tablets (75 mg) in participants of the China Health Study under fasting and fed dosing conditions.

主要研究目的：按有关生物等效性试验的规定，选择Pfizer Inc.为持证商的硫酸瑞美吉泮口崩片（商品名：乐泰可®/NURTEC®，规格：75mg）为参比制剂，对哈尔滨三联药业股份有限公司生产并提供的受试制剂硫酸瑞美吉泮口崩片（规格：75mg）进行空腹和餐后给药条件下的人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，评价两种制剂在空腹和餐后给药条件下的生物等效性。次要研究目的：观察健康研究参与者口服受试制剂硫酸瑞美吉泮口崩片（规格：75mg）和参比制剂硫酸瑞美吉泮口崩片（商品名：乐泰可®/NURTEC®，规格：75mg）的安全性。

[Translation]

The primary study objective was to conduct a bioequivalence study in humans using Remigipam Sulfate (orally disintegrating tablets, 75 mg) (trade name: Loctac®/NURTEC®) licensed by Pfizer Inc. as the reference product. The study compared the test product, Remigipam Sulfate (orally disintegrating tablets, 75 mg), produced and provided by Harbin Sanlian Pharmaceutical Co., Ltd., under both fasting and fed conditions. The study aimed to compare the drug absorption rate and extent of the test product with those of the reference product to determine if they were within acceptable limits and to evaluate the bioequivalence of the two products under both fasting and fed conditions. The secondary study objective was to observe the safety of the test product, Remigipam Sulfate (orally disintegrating tablets, 75 mg), and the reference product, Remigipam Sulfate (orally disintegrating tablets, 75 mg), when administered orally to healthy participants.

Start Date11 Oct 2025

Sponsor / Collaborator

Harbin Medisan Pharmaceutical Co., Ltd.

NCT06999252

/ Not yet recruitingPhase 2IIT

The Combination of Rimegepant and PD-1 Inhibitor in the Treatment of Liver Metastasis Colorectal Cancer

The goal of this clinical trial is to learn about efficacy of Rimegepant in combination with PD-1 in patients with liver metastasis colorectal cancer. The main question is to explore the survival time, safety and tolerability of the treatment. At the same time, the correlation between biomarkers (including PD-L1 expression, tumor mutation load, lymphocyte subpopulation, cytokines, TCR, intestinal microbes, and others) and the efficacy and drug resistance mechanism will be analyzed, so as to provide reference for the subsequent guidance of the screening of benefit groups.

Start Date01 Jul 2025

Sponsor / Collaborator

Fudan University

100 Clinical Results associated with Rimegepant Sulfate

100 Translational Medicine associated with Rimegepant Sulfate

100 Patents (Medical) associated with Rimegepant Sulfate

243

Literatures (Medical) associated with Rimegepant Sulfate

01 Nov 2025·CLINICAL NEUROLOGY AND NEUROSURGERY

Bridging CGRP mAbs with Gepants: An innovative approach to address the wearing-off phenomenon

Article

Author: Adel, Fatema ; Alsaffarini, Kareem ; Suliman, Reem ; El Jadam, Caline ; Pagdato, Beverly ; Alkhateri, Athra ; Alsaadi, Taoufik

INTRODUCTION:

The introduction of calcitonin gene-related peptide (CGRP)-targeted therapies, including monoclonal antibodies (mAbs) and gepants, has revolutionized migraine management by reducing attack frequency, severity, and duration. However, concerns have emerged regarding the potential wearing off effect, where treatment efficacy diminishes before the next scheduled dose. This study evaluates the long-term efficacy and safety of bridging CGRP mAbs with gepants across 16 clinic visits over 24 months of follow-up, to manage the wearing-off phenomenon of mAbs.

METHODS:

This was a retrospective, real-world, exploratory study. The participants included in the study were adult (≥ 18 years) patients diagnosed with migraine. Screening for patients who had received CGRP mAbs for a minimum of 12 months was done. Clinical data was collected from electronic medical records. A total of 439 patients with documented follow-up visits while taking CGRP mAbs were identified. Data was collected from one site, the American Center for Psychiatry and Neurology, Abu Dhabi, UAE.

RESULTS:

Out of the 493 patients, 65 patients had a wear-off effect of CGRP mAbs and were on bridging treatment. Eptinezumab (55.38 %) was the most prescribed CGRP mAb, followed by erenumab (26.15 %) and galcanezumab (18.46 %). Rimegepant (95.38 %) was the primary gepant used for bridging therapy. Weekly headache days (WHD) decreased significantly over the 16 visits, from 4 days at baseline to near zero by visit 16. 41.54 % of patients improved in severity, while 46.15 % remained stable.

CONCLUSION:

These findings strongly suggest the effectiveness of gepants in managing the wearing-off phenomenon across patients on mAbs. They also underscore the importance of individualized treatment approaches. While CGRP-targeted treatments remain highly effective, ongoing research is essential to optimize long-term use and minimize fluctuations in efficacy, ultimately improving patient reported outcomes.

28 Oct 2025·PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA

Single-cell sequencing uncovers sensory neuron–mediated CGRP signaling as a driver of sarcoma progression

Article

Author: Birbrair, Alexander ; Gomez-Salazar, Mario ; Zhong, Lingke ; McCarthy, Edward F. ; Guan, Yun ; James, Aaron W. ; Cherief, Masnsen ; Chang, Leslie ; Thottappillil, Neelima ; Ramesh, Sowmya ; Levi, Benjamin ; Xu, Mingxin ; Price, Theodore J. ; Zhu, Manyu ; Archer, Mary ; Uniyal, Ankit ; Bae, Sam ; Morris, Carol D. ; Clemens, Thomas L. ; Xing, Xin ; Qin, Qizhi ; Balaji, Devadutta ; Mittal, Monisha ; Li, Zhao ; Mazhar, Khadijah

Bone pain is a presenting feature of bone cancers such as osteosarcoma (OS), relayed by skeletal-innervating peripheral afferent neurons. Potential functions of tumor-associated sensory neurons in bone cancers beyond pain sensation are unknown. To uncover neural regulatory functions, a chemical-genetic approach in mice with a knock-in allele for TrkA was used to functionally perturb sensory nerve innervation during OS growth and disease progression. TrkA inhibition in transgenic mice led to significant reductions in sarcoma-associated sensory innervation and vascularization, skewed tumor associated macrophage polarization, reduced tumor growth and metastasis, and prolonged overall survival. Single-cell transcriptomics revealed that sarcoma denervation was associated with phenotypic alterations in both OS tumor cells and cells within the tumor microenvironment, and with reduced calcitonin gene-related peptide (CGRP) and vascular endothelial growth factor (VEGF) signaling. Multimodal and multiomics analyses of human OS bone samples further implicated peripheral innervation and neurotrophin signaling in OS tumor biology. Next and in two parallel approaches to inhibit nerve ingrowth, we repurposed FDA-approved bupivacaine liposomes and separately blocked CGRP signaling using FDA-approved Rimegepant. Both strategies led to significant reductions in sarcoma growth, vascularity, and sarcoma-induced hyperalgesia. In sum, TrkA-expressing peripheral neurons positively regulate key aspects of OS progression and sensory neural inhibition disrupts CGRP signaling within the sarcoma microenvironment leading to significantly reduced tumor growth and improved survival. These data suggest that interventions to prevent pathological innervation of OS represent an adjunctive therapy to improve clinical outcomes and survival.

01 Oct 2025·CEPHALALGIA

Rimegepant for the acute treatment of migraine: A phase 3, multicenter, open-label, long-term safety and effectiveness study in adults from China

Article

Author: Zhong, Qi ; Fountaine, Robert J. ; Zhang, Mingjie ; Han, Xiaoran ; Zhang, Yongbo ; Liu, Jianguang ; Pixton, Glenn C. ; Wu, Jin ; Lu, Zhihong ; Guo, Aihong ; Dong, Hongjuan ; Wang, Hebo ; Zhang, Bei ; Guo, Huailian ; Ma, Liheng ; Yu, Shengyuan ; Yu, Tingmin

Background:

This study evaluated the long-term safety, tolerability and effectiveness of rimegepant, 75 mg orally disintegrating tablet, for the acute treatment of migraine in Chinese adults.

Methods:

This phase 3, multicenter, open-label, single-arm study enrolled Chinese adults with a ≥1 year history of migraine (with or without aura), 6–18 moderate-to-severe migraine attacks/month within three months before a screening visit and at least six migraine days during a 30-day observation phase (OP). After the OP, eligible participants took rimegepant as needed (maximum one tablet per day) at the onset of mild-to-severe migraine attack for a long-term treatment (LTT) of 52 weeks.

Results:

Overall, 240 participants were treated and 208 (86.3%) completed the study. During LTT, 203 (84.6%) participants reported ≥1 treatment-emergent adverse event (TEAE) and 46 (19.2%) reported ≥1 TEAE considered to be rimegepant-related. There were no rimegepant-related serious AEs or rimegepant-related TEAEs that led to treatment interruption or discontinuation. Mean reduction from the OP in monthly migraine days was observed as early as the first four weeks (−1.7; 95% confidence interval = −2.2 to −1.2), with an overall mean reduction of −4.4 (95% confidence interval = −4.9 to −3.9) days across LTT.

Conclusions:

Rimegepant had a favorable long-term safety profile, was well tolerated in Chinese participants, and a reduction in the number of monthly migraine days was observed during the LLT.Trial registration: ClinicalTrials.gov identifier: NCT05371652

News (Medical) associated with Rimegepant Sulfate

17 Nov 2025

·pharma.economictimes.indiatimes.com

Pfizer launches gene-related peptide for migraine in India

New Delhi: Pfizer India arm has announced the launch of calcitonin gene-related peptide (CGRP) receptor antagonist: Rimegepant for acute treatment of migraine, in adults with a previous insufficient response to triptan. Rimegepant is designed to target migraine’s pathophysiology calcitonin gene-related peptide (CGRP) and delivers rapid and sustained pain relief lasting up to 48 hours post-treatment, while not associated with the risk of medication overuse headaches. It also enables early return to function and sustained relief from most bothersome symptoms. Rimegepant will be available in a 75 mg orally disintegrating tablet (ODT) form, designed for convenient administration without the need for water. “We believe this treatment will help people with migraine manage pain more effectively and reclaim productive days sooner than with currently available options,” said Meenakshi Nevatia, MD, Pfizer Ltd., India By Online Bureau ,

Gene TherapyDrug Approval

04 Nov 2025

·firstwordpharma.com

Pfizer ups profit forecast as it shrugs off downturn in COVID-19 sales

Pfizer raised its full-year profit forecast on Tuesday despite another sharp drop in sales of its COVID-19 products, boosted by the performance of its broader drug portfolio. It now expects adjusted 2025 earnings of $3.00 to $3.15 per share, up from a prior range of $2.90 to $3.10 per share, and reaffirmed its full-year revenue guidance of between $61 billion and $64 billion.Third-quarter revenues fell 6% year-over-year to $16.7 billion, hurt by waning demand for its COVID-19 vaccine Comirnaty and oral antiviral treatment Paxlovid, but still edged past the $16.6 billion analysts were expecting. Its net income was down 21% to $3.5 billion.Sales of Comirnaty dropped 19% to $1.2 billion as a narrower vaccine recommendation for COVID-19 in the US reduced the eligible population, while Paxlovid revenues plunged 55% to $1.23 billion amid lower global infection rates.Outside of COVID-19 product sales, Pfizer said a number of other drugs delivered. Eliquis brought in $2 billion during the quarter, up 25% on strong global demand and favourable US pricing tied to changes under Medicare's Part D redesign, which eliminated the coverage gap.The Vyndaqel family of heart drugs rose 10% to $1.6 billion, while migraine therapy Nurtec ODT/Vydura climbed 22% to $412 million. CFO David Denton said the company's non-COVID portfolio grew 4% operationally.More to follow.

VaccineFinancial Statement

30 Sep 2025

·www.einpresswire.com

April - June 2025 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

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Teriparatide injection (a particular generic product) Device malfunction FDA is evaluating the need for regulatory action. Vizamyl (flutemetamol F18 injection) Anaphylactic reaction The "Warnings and Precautions" section of the labeling was updated in June 2025 to include information about anaphylaxis and other serious hypersensitivity reactions. Vizamyl labeling Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Drug ApprovalBiosimilar

100 Deals associated with Rimegepant Sulfate

External Link

KEGG	Wiki	ATC	Drug Bank
-	Rimegepant Sulfate	N02C	DB12457

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Acute migraine	South Korea	Pfizer Pharmaceuticals Korea Ltd.	24 Mar 2025
Migraine Disorders	United States	Pfizer Inc.	27 Feb 2020

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Migraine Without Aura	Phase 3	United States	Pfizer Inc.	11 Mar 2025
Migraine Without Aura	Phase 3	China	Pfizer Inc.	11 Mar 2025
Migraine Without Aura	Phase 3	Japan	Pfizer Inc.	11 Mar 2025
Migraine Without Aura	Phase 3	Argentina	Pfizer Inc.	11 Mar 2025
Migraine Without Aura	Phase 3	Canada	Pfizer Inc.	11 Mar 2025
Migraine Without Aura	Phase 3	Denmark	Pfizer Inc.	11 Mar 2025
Migraine Without Aura	Phase 3	Germany	Pfizer Inc.	11 Mar 2025
Migraine Without Aura	Phase 3	India	Pfizer Inc.	11 Mar 2025
Migraine Without Aura	Phase 3	Italy	Pfizer Inc.	11 Mar 2025
Migraine Without Aura	Phase 3	Netherlands	Pfizer Inc.	11 Mar 2025

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05399459 (Pubmed \| Headache)	Phase 2/3	Migraine Disorders	706	Rimegepant 25 mg	vtwxhsoccz(ogprtrnmqd) = mjfuvmwtil chtctyyont (vgjffqvioq )	Positive	01 Nov 2025
				Rimegepant 75 mg	vtwxhsoccz(ogprtrnmqd) = aokjyzetji chtctyyont (vgjffqvioq )
NCT05371652 (Pubmed \| Cephalalgia)	Phase 3	Migraine Disorders	240	Rimegepant 75 mg	srlkfqlqtv(hwvmvphina) = wmbleylucf ygtharnpnt (tolruyjlgl ) View more	Positive	01 Oct 2025
NCT05207865 (CTgov)	Phase 4	Migraine Disorders \| Photophobia	441	Rimegepant	mlgvhdhqmr = qlxbyjpuul irxjtjhqcj (uoplfeearv, cmqiohadfc - smfddtgajo) View more	-	03 Sep 2025
NCT05399485 (Pubmed \| Headache)	Phase 3	Migraine Disorders	484	Rimegepant 75 mg	fiklqrztwz(egkhjateuz) = prjyhpatps vcbzuljphf (isyceszzbq, -1.73 to -0.38)	Positive	01 Sep 2025
NCT04629950 (CTgov)	Phase 2	Plaque psoriasis	41	Rimegepant (Rimegepant)	iegsyudwqm(zntpsiucad) = mlpphbcbqw vcjsfyvxjz (pgbbdixcrw, 34.43) View more	-	17 Jul 2025
				Placebo (Placebo)	iegsyudwqm(zntpsiucad) = rqppzmsalw vcjsfyvxjz (pgbbdixcrw, 32.58) View more
NCT05399485 (CTgov)	Phase 3	Migraine Disorders	496	Rimegepant (Rimegepant)	qocctvbjqn(vqarhrfxon) = dviidamcus hzsxpyrjyg (lcipjfebeb, fbdrahhict - nneomfccky) View more	-	14 Jul 2025
				Placebo (Placebo)	qocctvbjqn(vqarhrfxon) = bjyulubwpz hzsxpyrjyg (lcipjfebeb, prywcdvbeo - gkvnczpncc) View more
NCT03266588 (Pubmed \| Cephalalgia)	Phase 2/3	-	-	Triptan-naïve participants	zafffwscwk(uwoihtukty) = lpkpthurnl zsdgbxrxmk (quzoyrqgut ) View more	Positive	01 Jul 2025
				Triptan-using participants	zafffwscwk(uwoihtukty) = tqpyyvogfm zsdgbxrxmk (quzoyrqgut ) View more
NCT03732638 (Pubmed \| Headache)	Phase 2/3	Migraine Disorders	603	Rimegepant 75 mg EOD	mnqeozbmjf(xwybcqexpe) = n = 4, 0.7% fhkgbseyzd (yddlvjidlq ) View more	Positive	30 Jun 2025
NCT05399459 (P8-12.006, AAN2025)	Phase 2/3	Migraine Disorders	706	Rimegepant 25 mg	ilkbqujzzk(zfymtxlxsy) = nfdfwjdsqs ddrwgkgbti (eahoeiuwfi ) View more	Positive	07 Apr 2025
				Rimegepant 75 mg	ilkbqujzzk(zfymtxlxsy) = svzpchslio ddrwgkgbti (eahoeiuwfi ) View more
P1-12.008 (AAN2025)	Not Applicable	Migraine Disorders	-	Rimegepant users	epajzqiqps(nkoncnthxb) = sznjvfcsxr qziszoptzx (wqkykoiujr ) View more	Positive	07 Apr 2025
				Triptan users	epajzqiqps(nkoncnthxb) = rjkhakjtkt qziszoptzx (wqkykoiujr ) View more

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