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 Date17 Sep 2025

Sponsor / Collaborator

Pfizer Inc.

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

NCT06985342

/ RecruitingPhase 4IIT

A Prospective, Open-Label Study Examining the Use of Rimegepant ODT 75 mg or Zavegepant Nasal Spray 10 mg for Acute Treatment of Migraine in the Emergency Department Setting

This study evaluates the effectiveness of rimegepant 75 mg orally disintegrating tablet (ODT) single-dose or zavegepant 10 mg nasal spray single-dose as acute migraine treatments during Emergency Department (ED) encounters. Although these two calcitonin gene-related peptide receptors (CGRP) receptor antagonists are FDA-approved for the indication of acute migraine treatment, past studies have been limited to the outpatient setting. If these medications are effective in the Emergency Department, their delivery methods alone may have advantages over intravenous medications commonly used for acute migraine in EDs, including quicker time to treatment delivery, faster pain relief, and reduced ED length of stay. This investigation is a pilot study to examine rimegepant and zavegepant in an ED, to gain insight on effectiveness in this setting.
This study will administer rimegepant 75 mg ODT single-dose or zavegepant 10 mg nasal spray single-dose as acute migraine treatments to 100 patients in the Emergency Department. It is a single center, open-label, non-controlled 2-group clinical trial (allocated 1:1 to rimegepant or zavegepant via pseudo-random assignment). The study will enroll adults in the ED meeting ICHD-3 criteria for migraine or probable migraine, with or without aura.

Start Date05 Jun 2025

Sponsor / Collaborator

Icahn School of Medicine at Mount Sinai

[+1]

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

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)

Acetaminophen-containing products Anaphylactic reaction FDA is evaluating the need for regulatory action. Aptryxol (desvenlafaxine) DaTscan (ioflupane I 123 injection) Desvenlafaxine extended-release tablets Effexor XR (venlafaxine extended-release) capsules Pristiq (desvenlafaxine) extended-release tablets Venlafaxine (venlafaxine hydrochloride) extended-release tablets False positive radioisotope investigation test result potentially secondary to a drug interaction with venlafaxine FDA is evaluating the need for regulatory action. Barium sulfate-containing products Entero Vu 24% (barium sulfate) oral suspension E-Z-Disk (barium sulfate) tablets Liquid E-Z-Paque (barium sulfate) oral suspension Readi-Cat 2 (barium sulfate) oral suspension Readi-Cat 2 Smoothie (barium sulfate) oral suspension Taglitol V (barium sulfate) oral suspension Varibar Honey (barium sulfate) oral suspension Varibar Nectar (barium sulfate) oral suspension Varibar Pudding (barium sulfate) oral paste Varibar Thin Honey (barium sulfate) oral suspension Varibar Thin Liquid (barium sulfate) oral suspension Anaphylactic reaction FDA is evaluating the need for regulatory action. Blincyto (blinatumomab) for injection Columvi (glofitamab-gxbm) injection Elrexfio (elranatamab-bcmm) injection Epkinly (epcoritamab-bysp) injection Imdelltra (tarlatamab-dlle) for injection Kimmtrak (tebentafusp-tebn) injection Lunsumio (mosunetuzumab-axgb) injection Talvey (talquetamab-tgvs) injection Tecvayli (teclistamab-cqyv) injection Progressive multifocal leukoencephalopathy FDA is evaluating the need for regulatory action. BRAF kinase inhibitors Braftovi (encorafenib) capsules Ojemda (tovorafenib) for oral suspension; tablets Tafinlar (dabrafenib) capsules; tablets Zelboraf (vemurafenib) tablets Gingival hypertrophy FDA is evaluating the need for regulatory action. Briumvi (ublituximab-xiiy) injection Kesimpta (ofatumumab) injection Acute hepatic failure The "Warnings and Precautions" section of the labeling was updated in August 2025 to include information about liver injury. Example: Briumvi labeling Briumvi (ublituximab-xiiy) injection Kesimpta (ofatumumab) injection Ocrevus (ocrelizumab) injection Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) injection Central nervous system infection FDA is evaluating the need for regulatory action. Crexont (carbidopa and levodopa) extended-release capsules Dhivy (carbidopa and levodopa) tablets Duopa (carbidopa and levodopa) enteral suspension Rytary (carbidopa and levodopa) extended-release capsules Sinemet (carbidopa and levodopa) tablets Sinemet CR (carbidopa and levodopa) sustained-release tablets Stalevo (carbidopa, levodopa and entacapone) tablets Vyalev (foscarbidopa and foslevodopa) injection Seizure FDA is evaluating the need for regulatory action. Crysvita (burosumab-twza) injection Hypercalcemia The "Dosage and Administration", "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in August 2025 to include information about hypercalcemia. Crysvita labeling Dexmedetomidine-containing products Dexmedetomidine injection Precedex (dexmedetomidine hydrochloride) injection Igalmi (dexmedetomidine) sublingual film Diabetes insipidus FDA is evaluating the need for regulatory action. Dupixent (dupilumab) injection Ocular infections, irritations, and inflammation FDA is evaluating the need for regulatory action. Eprontia (topiramate) oral solution Qudexy XR (topiramate) extended-release capsules Qsymia (phentermine and topiramate) extended-release capsules Topamax (topiramate) tablets Topamax Sprinkle (topiramate) capsules Trokendi XR (topiramate) extended-release capsules Hypersensitivity FDA is evaluating the need for regulatory action. Gavreto (pralsetinib) capsules Chylothorax FDA is evaluating the need for regulatory action. Glucagon-like peptide-1 (GLP-1) receptor agonists Adlyxin (lixisenatide) injection Bydureon (exenatide) for extended-release injectable suspension Bydureon BCise (exenatide extended-release) injectable suspension Byetta (exenatide) injection Mounjaro (tirzepatide) injection Ozempic (semaglutide) injection Rybelsus (semaglutide) tablets Saxenda (liraglutide) injection Soliqua 100/33 (insulin glargine and lixisenatide) injection Trulicity (dulaglutide) injection Victoza (liraglutide) injection Wegovy (semaglutide) injection Xultophy 100/3.6 (insulin degludec and liraglutide) injection Zepbound (tirzepatide) injection Intestinal obstruction and fecal impaction FDA is evaluating the need for regulatory action. Imbruvica (ibrutinib) capsules; tablets; oral suspension Nail and nail bed conditions (excluding infections and infestations) FDA is evaluating the need for regulatory action. MEK inhibitors Avmapki Fakzynja Co-pack (avutometinib capsules; defactinib tablets) Cotellic (cobimetinib) tablets Mekinist (trametinib) tablets; oral solution Mektovi (binimetinib) tablets Koselugo (selumetinib) capsules Gingival hypertrophy FDA is evaluating the need for regulatory action. Neffy (epinephrine nasal spray) Product storage error FDA is evaluating the need for regulatory action. Nurtec ODT (rimegepant) orally disintegrating tablets Zavzpret (zavegepant) nasal spray Anaphylactic reaction The "Contraindications" and "Warnings and Precautions" sections of the labeling were updated in August 2025 to include information about hypersensitivity reactions, including anaphylaxis. Example: Nurtec ODT labeling Rozlytrek (entrectinib) capsules; oral pellets Brugada syndrome FDA is evaluating the need for regulatory action. Sodium-glucose cotransporter-2 (SGLT2) inhibitors Fournier's gangrene FDA is evaluating the need for regulatory action. 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

29 Aug 2025

·www.einpresswire.com

July - September 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Ajovy (fremanezumab-vfrm) Emgality (galcanezumab-gnlm) Nurtec ODT (rimegepant) Ubrelvy (ubrogepant) Vyepti (eptinezumab-jjmr) Hypertension The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in March 2025 to include information about the risk of hypertension. Example: Ajovy labeling Apriso (mesalamine) Asacol (mesalamine) Asacol HD (mesalamine) Azulfidine (sulfasalazine) Azulfidine EN-Tabs (sulfasalazine) Canasa (mesalamine) Colazal (balsalazide disodium) Delzicol (mesalamine) Dipentum (osalazine sodium) Giazo (balsalazide disodium) Lialda (mesalamine) Rowasa (mesalamine) Pentasa (mesalamine) Severe cutaneous adverse reactions The Warnings and Precautions section of the labeling was updated November 2021 to include severe cutaneous adverse reactions. Example: Delzicol labeling Avastin (bevacizumab) Mvasi (bevacizumab-awwb) Zirabev (bevacizumab-bvzr) Pancreatitis FDA determined that no action is necessary at the time based on available information. Avastin (bevacizumab) Mvasi (bevacizumab-awwb) Zirabev (bevacizumab-bvzr) Anaphylactic shock The "Warnings and Precautions" section of the labeling was updated between September 2022 and February 2023 to include anaphylactoid/anaphylactic reactions. Example: Avastin labeling Ayvakit (avapritinib) Photosensitivity reaction The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in March 2023 to include information about photosensitivity. Ayvakit labeling Azacitidine Onureg (azacitidine) Vidaza (azacitidine) Generic products containing azacitidine Pericarditis The "Adverse Reactions" section of the labeling was updated between September 2022 and June 2023 to include pericarditis. Example: Vidaza labeling FDA determined that no action is necessary at the time based on available information for Onureg. Bavencio (avelumab) Imfinzi (durvalumab) Libtayo (cemiplimab-rwlc) Keytruda (pembrolizumab) Opdivo (nivolumab) Tecentriq (atezolizumab) Yervoy (ipilimumab) Tumour lysis syndrome FDA determined that no action is necessary at the time based on available information. Cymbalta (duloxetine hydrochloride) Drizalma Sprinkle (duloxetine hydrochloride) Generic products containing duloxetine hydrochloride Anosmia, Hyposmia This issue is posted as two individual newly identified safety signal (NISS) entries in the January-March 2022 quarter, to reflect the focus on the potential signals of anosmia and hyposmia, separately. Darzalex (daratumumab) Darzalex Faspro (daratumumab and hyaluronidase-fihj) Blood stem cell transplant failure FDA determined that no action is necessary at the time based on available information. Dipeptidyl peptidase-4 (DPP-4) inhibitors Glyxambi (empagliflozin and linagliptin) Janumet (metformin hydrochloride and sitagliptin phosphate) Janumet XR (metformin hydrochloride and sitagliptin phosphate) Jentadueto (linagliptin and metformin hydrochloride) Jentadueto XR (linagliptin and metformin hydrochloride) Kazano (alogliptin and metformin hydrochloride) Kombiglyze XR (metformin hydrochloride and saxagliptin) Nesina (alogliptin) Onglyza (saxagliptin) Oseni (alogliptin and pioglitazone) Steglujan (ertugliflozin and sitagliptin) Tradjenta (linagliptin) Trijardy XR (empagliflozin, linagliptin and metformin hydrochloride) Qtern (saxagliptin and dapagliflozin) Generic products containing dipeptidyl peptidase-4 inhibitors Tubulointerstitial nephritis The "Adverse Reactions" section of the labeling was updated between March 2022 and June 2022 for products containing alogliptin and sitagliptin to include tubulointerstitial nephritis. Example: Janumet labeling FDA determined that no action is necessary for products containing linagliptin and saxagliptin at the time based on available information. *An administrative error resulted in the omission of Januvia from the list of product names after the initial quarterly report was posted. Dupixent (dupilumab) Angioedema The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in December 2021 to include angioedema. Dupixent labeling Glucagon-like peptide-1 (GLP-1) analogues Adlyxin (lixisenatide) Bydureon (exenatide) Bydureon BCise (exenatide) Byetta (exenatide) Ozempic (semaglutide) Rybelsus (semaglutide) Saxenda (liraglutide) Soliqua 100/33 (insulin glargine and lixisenatide injection) Trulicity (dulaglutide) Victoza (liraglutide) Wegovy (semaglutide) Xultophy 100/3.6 (insulin degludec and liraglutide injection) Generic products containing glucagon-like peptide-1 analogues Gallbladder related disorders The "Warnings and Precautions", "Adverse Reactions", and "Patient Counseling Information" sections of the GLP-1 analogues labeling were updated between March 2022 and June 2022 to include information about acute gallbladder disease. Example: Adlyxin labeling FDA has determined that the last approved labeling for Saxenda and Wegovy is adequately labeled for acute gallbladder disease, and that no further regulatory action is needed at this time. Gonadotropin releasing hormone (GnRH) analogues Fensolvi (leuprolide acetate) Lupron Depot-PED (leuprolide acetate) Supprelin LA (histrelin acetate) Synarel (nafarelin acetate) Triptodur (triptorelin) Idiopathic intracranial hypertension The "Warnings", "Precautions", and "Adverse Reactions" sections of the labeling were updated in April 2022 to include idiopathic intracranial hypertension. Example: Fensolvi labeling Jakafi (ruxolitinib phosphate) Herpes simplex virus (HSV) reactivation and/or disseminated HSV The "Dosage and Administration", "Warnings and Precautions", and "Adverse Reactions" sections of the labeling were updated in January 2023 to include information about herpes simplex and herpes zoster infections. Jakafi labeling Ibrance (palbociclib) Kisqali (ribociclib) Kisqali Femara Co-Pack (letrozole and ribociclib) Embolic and thrombotic events, venous The "Adverse Reactions" section of the Ibrance labeling was updated in December 2024 to include venous thromboembolism. Ibrance labeling FDA determined that no action is necessary at the time for Kisqali and Kisqali Femara Co-Pack based on available information. Ocrevus (ocrelizumab) Myocardial infarction FDA determined that no action is necessary at the time based on available information. Potassium Chloride Product preparation error The “Warnings” section of the labeling was updated in December 2022 to include information about fatal cardiac adverse reactions with intravenous administration of undiluted potassium chloride. Praxbind (idarucizumab) Wrong dose errors The carton labeling and "Dosage and Administration" sections of the labeling were revised in February 2022 to clarify the number of vials included in each carton and the recommended dosing. Praxbind labeling Qbrexza (glycopyrronium tosylate) Accidental exposure to product The container label, carton labeling, "Dosage and Administration", "Warnings and Precautions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in October 2022 to include information about accidental exposure. Qbrexza labeling Qbrexza (glycopyrronium tosylate) Urinary retention The “Warnings and Precautions”, “Adverse Reactions”, and “Patient Counseling Information” sections of the labeling were updated in October 2022 to include information about new or worsening urinary retention. Qbrexza labeling Sodium-glucose cotransporter-2 (SGLT-2) inhibitors Farxiga (dapagliflozin) Glyxambi (empagliflozin and linagliptin) Invokamet (canagliflozin and metformin hydrochloride) Invokamet XR (canagliflozin and metformin hydrochloride) Invokana (canagliflozin) Jardiance (empagliflozin) Qtern (saxagliptin and dapagliflozin) Steglatro (ertugliflozin) Steglujan (ertugliflozin and sitagliptin) Segluromet (ertugliflozin and metformin hydrochloride) Synjardy (empagliflozin and metformin hydrochloride) Synjardy XR (empagliflozin and metformin hydrochloride) Trijardy XR (empagliflozin, linagliptin and metformin hydrochloride) Xigduo XR (dapagliflozin and metformin) Generic products containing sodium-glucose cotransporter-2 (SGLT-2) inhibitors Tubulointerstitial nephritis FDA determined that no action is necessary at the time based on available information. Somatostatin Receptor Imaging Agents Detectnet (copper Cu-64 dotatate injection) Gallium Dotatoc (GA 68) Octreoscan (Indium In 111 Pentetreotide) Netspot (Gallium GA 68 Dotatate) Hypersensitivity The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in December 2021 to include hypersensitivity reactions. Example: Netspot labeling Stromectol (ivermectin) Generic products containing ivermectin Off label use FDA determined that no action is necessary at the time based on available information. Stromectol (ivermectin) Generic products containing ivermectin Neurotoxicity The "Warnings", "Adverse Reactions", and "Overdosage" sections of the labeling were updated in March 2022 to include neurotoxicity. Example: Stromectol labeling Sunosi (solriamfetol hydrochloride) Hypersensitivity FDA determined that no action is necessary at the time based on available information. Vivitrol (naltrexone) Incorrect route of product administration The container label (vial), carton labeling, "Dosage and Administration", "Warnings and Precautions", and "Description", sections of the labeling were revised in September 2022 to emphasize the appropriate route and site of administration. Vivitrol labeling Xcopri (cenobamate) Psychiatric disorders The "Adverse Reactions" section of the labeling was updated in June 2022 to include psychiatric disorders. Xcopri 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 Approval

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	Italy	Pfizer Inc.	11 Mar 2025
Migraine Without Aura	Phase 3	Poland	Pfizer Inc.	11 Mar 2025
Migraine Without Aura	Phase 3	South Korea	Pfizer Inc.	11 Mar 2025

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05371652 (Pubmed \| Cephalalgia)	Phase 3	Migraine Disorders	240	Rimegepant 75 mg	osmzhoskoj(ojphvwcnpi) = zujdavokhr celbhmynlv (pjbhwzkqyo ) View more	Positive	01 Oct 2025
NCT05207865 (CTgov)	Phase 4	Migraine Disorders \| Photophobia	441	Rimegepant	rnjlfchgeu = zvtuwrzcfp czvwzvoowv (trtujdesmv, lslpeyzglw - bnxtekamgi) View more	-	03 Sep 2025
NCT04629950 (CTgov)	Phase 2	Plaque psoriasis	41	Rimegepant (Rimegepant)	bjjlockcfa(gqsaocysnn) = lmnslltxzp ddhhfvyvho (wfzoiljnnb, 34.43) View more	-	17 Jul 2025
				Placebo (Placebo)	bjjlockcfa(gqsaocysnn) = hclbwrbifd ddhhfvyvho (wfzoiljnnb, 32.58) View more
NCT05399485 (CTgov)	Phase 3	Migraine Disorders	496	Rimegepant (Rimegepant)	xkldlachzy(wtdfwhamja) = holqyktorq imiojiftgp (wykgmtoahs, enkhlhkplr - dxydqzkwbj) View more	-	14 Jul 2025
				Placebo (Placebo)	xkldlachzy(wtdfwhamja) = yaopwpnbuh imiojiftgp (wykgmtoahs, ihyaxrwjvq - zgzoarkvgz) View more
NCT03266588 (Pubmed \| Cephalalgia)	Phase 2/3	-	-	Triptan-naïve participants	lhjuygybig(jfeswbrpzc) = wepvorukxl ucxrgizgri (iouwqjnhgv ) View more	Positive	01 Jul 2025
				Triptan-using participants	lhjuygybig(jfeswbrpzc) = sjedgkqcaw ucxrgizgri (iouwqjnhgv ) View more
NCT05399459 (Pubmed \| Headache)	Phase 2/3	Migraine Disorders	706	Rimegepant 25 mg	yankainhij(ogkvshhbjn) = wjogglkflo fpfnonwqfa (munbbwbqvr )	Positive	30 Jun 2025
				Rimegepant 75 mg	yankainhij(ogkvshhbjn) = itruoanjdb fpfnonwqfa (munbbwbqvr )
NCT03732638 (Pubmed \| Headache)	Phase 2/3	Migraine Disorders	603	Rimegepant 75 mg EOD	isiepmrris(ixvncyqqtk) = n = 4, 0.7% xggfuukslb (rstyqojrhe ) View more	Positive	30 Jun 2025
NCT05399485 (Pubmed \| Headache)	Phase 3	Migraine Disorders	484	Rimegepant 75 mg	wxhcfdudxb(ztyyoslxmm) = xerruifwir tshxlkbzsu (rvljyjsfum, -1.73 to -0.38)	Positive	20 Jun 2025
NCT05399459 (P8-12.006, AAN2025)	Phase 2/3	Migraine Disorders	706	Rimegepant 25 mg	hjyovurmjs(vyoyktdjyt) = uprolmihcv zmeethanlv (zudrnawvhb ) View more	Positive	07 Apr 2025
				Rimegepant 75 mg	hjyovurmjs(vyoyktdjyt) = dfdtmqixaj zmeethanlv (zudrnawvhb ) View more
P1-12.008 (AAN2025)	Not Applicable	Migraine Disorders	-	Rimegepant users	ccetmzjwru(lvulmeeciy) = tximsqjkjh tsqbinozso (mfpiucmjzm ) View more	Positive	07 Apr 2025
				Triptan users	ccetmzjwru(lvulmeeciy) = ewimcakmxf tsqbinozso (mfpiucmjzm ) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis