Drugs / Fremanezumab
Fremanezumab
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | AJOVY | — | 2020-01-27 – 2025-08-05 | fda.gov ↗ |
| Approved | EU (EMA) | Ajovy | — | 2019-03-28 | europa.eu ↗ |
| Approved | US (FDA) | AJOVY | — | 2018-09-14 | fda.gov ↗ |
Trials 30 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 4 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT04334408 Comparator | Dec 2021 → Dec 2024 | cerebral arteriopathy, autosomal dominant, with subcortical infarcts and leukoencephalopathy, type 1, migraine disorder | Mayo Clinic | Withdrawn | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT07653516 Comparator | Jun → Jul 2027 expected | acute mountain sickness | Insel Gruppe AG, University Hospital Bern | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06173661 Comparator | Mar 2024 → Jul 2026 overdue | migraine disorder | Brigham and Women's Hospital | Active not recruiting | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT07071506 Comparator | Jun 2025 → Sep 2028 expected | migraine disorder | University of Aarhus | Recruiting | No outcome recorded |
Press releases naming this drug 76 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-01-14 | Teva Branded Pharmaceutical Products R&D, Inc. | AJOVY® (fremanezumab-vfrm) Significantly Reduced Monthly Migraine and Headache Days in Children and Adolescents with Episodic Migraine Compared to Placebo in the SPACE Trial; Results Published in New England Journal of Medicine tevapharm.com ↗ |
| 2026-01-14 | Teva Branded Pharmaceutical Products R&D, Inc. | AJOVY® (fremanezumab-vfrm) Significantly Reduced Monthly Migraine and Headache Days in Children and Adolescents with Episodic Migraine Compared to Placebo in the SPACE Trial; Results Published in New England Journal of Medicine tevapharm.com ↗ |
| 2025-08-06 | Teva Branded Pharmaceutical Products R&D, Inc. | FDA Approves Expanded Indication for AJOVY® (fremanezumab-vfrm), The First Anti-CGRP Preventive Treatment for Pediatric Episodic Migraine tevapharm.com ↗ |
| 2025-08-06 | Teva Branded Pharmaceutical Products R&D, Inc. | FDA Approves Expanded Indication for AJOVY® (fremanezumab-vfrm), The First Anti-CGRP Preventive Treatment for Pediatric Episodic Migraine tevapharm.com ↗ |
| 2025-06-23 | Teva Branded Pharmaceutical Products R&D, Inc. | Final Data from Teva’s PEARL Real-World Study Reinforce the Long-term Effectiveness of AJOVY® (fremanezumab) for the Prevention of Chronic and Episodic Migraine tevapharm.com ↗ |
| 2025-06-23 | Teva Branded Pharmaceutical Products R&D, Inc. | Final Data from Teva’s PEARL Real-World Study Reinforce the Long-term Effectiveness of AJOVY® (fremanezumab) for the Prevention of Chronic and Episodic Migraine tevapharm.com ↗ |
| 2025-04-07 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces FDA Filing Acceptance for AJOVY® (fremanezumab) in Pediatric Episodic Migraine Prevention tevapharm.com ↗ |
| 2025-04-07 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces FDA Filing Acceptance for AJOVY® (fremanezumab) in Pediatric Episodic Migraine Prevention tevapharm.com ↗ |
| 2024-12-04 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Presents Positive Efficacy and Safety Data of AJOVY® (fremanezumab) for the Prevention of Episodic Migraine in Children and Adolescents from Phase 3 SPACE Trial tevapharm.com ↗ |
| 2024-12-04 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Presents Positive Efficacy and Safety Data of AJOVY® (fremanezumab) for the Prevention of Episodic Migraine in Children and Adolescents from Phase 3 SPACE Trial tevapharm.com ↗ |
| 2024-07-18 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces First Phase 3 Evidence of Efficacy and Safety of an Anti-CGRP Monoclonal Antibody in Children in AJOVY® (fremanezumab) SPACE Trial for Prevention of Episodic Migraine tevapharm.com ↗ |
| 2024-06-28 | Teva Branded Pharmaceutical Products R&D, Inc. | New AJOVY® (fremanezumab) Migraine Prevention Data Challenges Treatment Pauses tevapharm.com ↗ |
| 2024-04-11 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Confirms Efficacy and Safety of AJOVY® (fremanezumab) for the Prevention of Migraine With Results from Phase 3 Trial in China tevapharm.com ↗ |
| 2023-12-06 | Teva Branded Pharmaceutical Products R&D, Inc. | New Post Hoc Phase 3 Data Analysis Shows AJOVY® (fremanezumab) Reduced Migraine Attacks in Adults with Migraine and Co-morbid Obesity tevapharm.com ↗ |
| 2023-10-17 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Phase IV UNITE Study Shows AJOVY® (fremanezumab) Reduced Migraine Attacks and Depression Symptoms in Migraine Sufferers with Major Depressive Disorder tevapharm.com ↗ |
| 2023-06-30 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva’s 3rd interim analysis of PEARL real-world study on AJOVY® (fremanezumab) reveals sustained long-term effectiveness in reducing frequency, duration and severity of attacks in patients with chronic and episodic migraine tevapharm.com ↗ |
| 2023-06-15 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva to Present Data at the 2023 American Headache Society Annual Scientific Meeting Demonstrating AJOVY® (fremanezumab-vfrm) Injection Significantly Reduced Migraine and Depression Symptoms in Patients tevapharm.com ↗ |
| 2022-09-08 | Teva Branded Pharmaceutical Products R&D, Inc. | Studies Show Effectiveness of AJOVY®▼ (fremanezumab) for Treatment of Migraine in Patients With Co-morbid Depression tevapharm.com ↗ |
| 2022-06-24 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Promising Interim Results From Its Study PEARL, About the Impact of AJOVY® (fremanezumab) tevapharm.com ↗ |
| 2022-06-09 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva to Present Latest Data on AJOVY® (fremanezumab-vfrm) Injection at the 2022 American Headache Society Annual Meeting tevapharm.com ↗ |
| 2022-06-09 | Teva Branded Pharmaceutical Products R&D, Inc. | New Real-World Data Evaluating AJOVY® (fremanezumab-vfrm) Injection Use in Patients With Migraine Presented at 2022 American Headache Society Annual Meeting tevapharm.com ↗ |
| 2022-04-01 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva to Present New Analyses of AJOVY® (fremanezumab-vfrm) Injection and AUSTEDO® (deutetrabenazine) Tablets at 2022 American Academy of Neurology Annual Meeting tevapharm.com ↗ |
| 2021-09-30 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva to Present 8 Abstracts on AJOVY® (fremanezumab-vfrm) Injection and Hold Symposium on Healthcare Disparities at WCN tevapharm.com ↗ |
| 2021-09-08 | Teva Branded Pharmaceutical Products R&D, Inc. | Late-Breaking Data at the International Headache Society & European Headache Federation Joint Congress 2021 Showed AJOVY® (fremanezumab-vfrm) Injection Reduced More Monthly Migraine Days in a Network Meta-Analysis Study with Atogepant and Rimegepant tevapharm.com ↗ |
| 2021-08-30 | Teva Branded Pharmaceutical Products R&D, Inc. | Showcasing Teva’s Commitment to Helping Patients Have More Migraine-Free Days, 18 Abstracts will be presented, Including One Late-Breaker, on AJOVY® (fremanezumab-vfrm) Injection at the International Headache Society and European Headache... tevapharm.com ↗ |
| 2021-06-23 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Ministry of Health, Labour and Welfare Approves AJOVY® (fremanezumab) Injection in Japan for the Preventive Treatment of Migraine in Adults tevapharm.com ↗ |
| 2021-06-21 | Teva Branded Pharmaceutical Products R&D, Inc. | New Data Supporting the Safety and Efficacy Profile of AJOVY® (fremanezumab) Shared at 7th European Academy of Neurology Congress tevapharm.com ↗ |
| 2021-06-03 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva to Present Latest Data on AJOVY® (fremanezumab-vfrm) Injection at the 2021 American Headache Society (AHS) Annual Meeting, Showcasing Teva’s Longstanding Heritage in the Management of Migraine tevapharm.com ↗ |
| 2021-06-03 | Teva Branded Pharmaceutical Products R&D, Inc. | New Clinical and Real-World Data Evaluating Efficacy of AJOVY® (fremanezumab-vfrm) Injection Presented at 2021 American Headache Society (AHS) Annual Meeting tevapharm.com ↗ |
| 2021-04-19 | Teva Branded Pharmaceutical Products R&D, Inc. | New Clinical and Real-World Data Evaluating Efficacy of AJOVY® (fremanezumab-vfrm) Injection and Reduction of Migraine Burden Presented at 2021 American Academy of Neurology Virtual Annual Meeting tevapharm.com ↗ |
| 2021-04-15 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva to Present New Analyses of AJOVY® (fremanezumab-vfrm) Injection and AUSTEDO® (deutetrabenazine) Tablets at Upcoming 2021 American Academy of Neurology Virtual Annual Meeting, Highlighting Teva’s Ongoing Commitment to Neurology tevapharm.com ↗ |
| 2020-10-07 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces New Analysis of Consistency in Migraine Days Over the Course of a Dosing Regimen for AJOVY® (fremanezumab-vfrm) Injection Published in Headache tevapharm.com ↗ |
| 2020-09-15 | Teva Branded Pharmaceutical Products R&D, Inc. | First Long-Term Data on the use of AJOVY® (fremanezumab-vfrm) Injection in Patients with Migraine Published in Neurology tevapharm.com ↗ |
| 2020-07-29 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Filed Application in Japan for Approval of Fremanezumab as a Prophylactic Treatment for Migraine otsuka.co.jp ↗ |
| 2020-07-29 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces New Drug Application Filing in Japan for AJOVY® (fremanezumab) Injection tevapharm.com ↗ |
| 2020-06-18 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Presents New Analyses Examining Changes in Migraine Disability Outcome Measurements with AJOVY® (fremanezumab-vfrm) Injection tevapharm.com ↗ |
| 2020-06-15 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva to Present New Data on AJOVY® (fremanezumab-vfrm) Injection Open-Label Extension Study at American Headache Society Annual Meeting tevapharm.com ↗ |
| 2020-05-25 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Presented New Data at the European Academy of Neurology Congress Evaluating the AJOVY® (fremanezumab) Experience in Populations with Difficult-to-Treat Migraine tevapharm.com ↗ |
| 2020-05-22 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva to Present New AJOVY® (fremanezumab) Analyses and Latest COPAXONE® Data (glatiramer acetate injection) at European Academy of Neurology Congress tevapharm.com ↗ |
| 2020-05-01 | Teva Branded Pharmaceutical Products R&D, Inc. | New Data For Teva AJOVY® (fremanezumab-vfrm) Injection and AUSTEDO® (deutetrabenazine) Tablets Included in Neurology tevapharm.com ↗ |
| 2020-04-27 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces U.S. Launch of Autoinjector for AJOVY® (fremanezumab-vfrm) Injection tevapharm.com ↗ |
| 2020-03-12 | Teva Branded Pharmaceutical Products R&D, Inc. | Positive Recommendation by NICE for first anti-CGRP migraine therapy: AJOVY®▼ (fremanezumab) tevapharm.com ↗ |
| 2020-02-03 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Positive Top-Line Results from AJOVY® (fremanezumab) Clinical Trials in Japan tevapharm.com ↗ |
| 2020-01-28 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces FDA Approval of AJOVY® (fremanezumab-vfrm) Injection Autoinjector tevapharm.com ↗ |
| 2019-10-24 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva to Present New Analyses of Fremanezumab and Country-Specific Burden of Migraine at 24th World Congress of Neurology tevapharm.com ↗ |
| 2019-09-04 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva to Present New Analyses of Fremanezumab Efficacy and Safety in Adult Patients with Difficult-to-Treat Migraine at 19th Congress of the International Headache Society tevapharm.com ↗ |
| 2019-09-03 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva to Present New Analyses of Fremanezumab Efficacy and Safety in Adult Patients with Difficult-to-Treat Migraine at 19th Congress of the International Headache Society tevapharm.com ↗ |
| 2019-08-21 | Teva Branded Pharmaceutical Products R&D, Inc. | Fremanezumab Data in The Lancet Demonstrate Clinically Meaningful Reduction in Monthly Migraine Days Versus Placebo for Patients with Difficult-To-Treat Migraine tevapharm.com ↗ |
| 2019-07-10 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva to Present New Data on AJOVY® (fremanezumab-vfrm) Injection at the American Headache Society’s 61st Annual Scientific Meeting tevapharm.com ↗ |
| 2019-07-02 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Presents Positive Results Showing Improvement in Disability and Quality of Life from the Phase IIIb FOCUS study of Fremanezumab in Adults with Migraine tevapharm.com ↗ |
| 2019-05-29 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva to present new fremanezumab FOCUS Clinical Study Data for the first time at the 13th European Headache Federation Congress tevapharm.com ↗ |
| 2019-05-03 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva to Present New Long-Term Data on Efficacy and Safety of Fremanezumab at 2019 American Academy of Neurology Annual Meeting tevapharm.com ↗ |
| 2019-04-23 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Update on Fremanezumab Clinical Development for use in Episodic Cluster Headache tevapharm.com ↗ |
| 2019-02-01 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Receives Positive Committee for Medicinal Products for Human Use (CHMP) Opinion for AJOVY® (fremanezumab) for the Prophylaxis of Migraine in Adults tevapharm.com ↗ |
| 2018-12-17 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Positive Topline Phase IIIb Results with Fremanezumab in Adults with Migraine Who Did Not Respond to Multiple Classes of Preventive Treatments tevapharm.com ↗ |
| 2018-09-14 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces U.S. Approval of AJOVY™ (fremanezumab-vfrm) Injection, the First and Only Anti-CGRP Treatment with Both Quarterly and Monthly Dosing for the Preventive Treatment of Migraine in Adults tevapharm.com ↗ |
| 2018-06-28 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva to Present New Fremanezumab Data, Including Long-Term Data, at the American Headache Society’s 60th Annual Scientific Meeting tevapharm.com ↗ |
| 2018-06-15 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Provides Update on Clinical Trial of Fremanezumab for Use in Chronic Cluster Headache tevapharm.com ↗ |
| 2018-05-23 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Confirms September PDUFA Date for Fremanezumab tevapharm.com ↗ |
| 2018-05-15 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Publication of Phase III Trial Data of Fremanezumab for the Preventive Treatment of Episodic Migraine in the Journal of the American Medical Association tevapharm.com ↗ |
| 2018-02-02 | Teva Branded Pharmaceutical Products R&D, Inc. | European Medicines Agency (EMA) Accepts Fremanezumab Marketing Authorization Application tevapharm.com ↗ |
| 2017-12-18 | Teva Branded Pharmaceutical Products R&D, Inc. | FDA Accepts Biologics License Application for Fremanezumab with Priority Review for Prevention of Migraine and Grants Fast Track Designation for Cluster Headache Development Program tevapharm.com ↗ |
| 2017-11-29 | Teva Branded Pharmaceutical Products R&D, Inc. | The New England Journal of Medicine Publishes Data from Pivotal Phase III Trial of Fremanezumab for the Preventive Treatment of Chronic Migraine tevapharm.com ↗ |
| 2017-10-17 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Submission of Biologics License Application for Fremanezumab to the U.S. FDA tevapharm.com ↗ |
| 2017-09-09 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Showcases Data Demonstrating Potential of Fremanezumab to Address Significant Unmet Need in Patients with Chronic and Episodic Migraine tevapharm.com ↗ |
| 2017-09-05 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva to Present Fremanezumab Data on Migraine Prevention at the 18th Congress of the International Headache Society tevapharm.com ↗ |
| 2017-06-07 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva's Fremanezumab Meets all Primary & Secondary Endpoints Across Both Monthly and Quarterly Dosing Regimens in Phase III Study in Episodic Migraine Prevention tevapharm.com ↗ |
| 2017-05-31 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Positive Results for Phase III Study of Fremanezumab for the Prevention of Chronic Migraine tevapharm.com ↗ |
| 2017-05-15 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka and Teva Sign Licensing Agreement for Japan on Prophylactic Migraine Drug Candidate Fremanezumab (TEV-48125) otsuka.co.jp ↗ |
| 2017-05-15 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka and Teva Sign Licensing Agreement for Japan on Prophylactic Migraine Drug Candidate Fremanezumab (TEV-48125) otsuka-us.com ↗ |
| 2017-05-15 | Teva Branded Pharmaceutical Products R&D, Inc. | Otsuka and Teva Sign Licensing Agreement for Japan on Prophylactic Migraine Drug Candidate Fremanezumab (TEV-48125) tevapharm.com ↗ |
| 2015-09-30 | Teva Branded Pharmaceutical Products R&D, Inc. | Important New Data from Teva's TEV-48125 Phase 2B Migraine Program Published in Lancet Neurology in Back-to-Back Articles tevapharm.com ↗ |
| 2015-06-18 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva to Present New Findings at the American Headache Society (AHS) Meeting – Analysis of Migraine Phase IIb Studies Provides Novel Insights into TEV-48125 Efficacy and Safety in Both Episodic & Chronic Migraine tevapharm.com ↗ |
| 2015-05-14 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Presents Further Data from Phase IIb with TEV-48125 in Chronic Migraine at the International Headache Society Congress (IHC): Efficacy and Safety Results at All Doses and Endpoints Present Robust Case for Progression to Phase III tevapharm.com ↗ |
| 2015-03-23 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva’s TEV-48125 Meets Primary and Secondary Endpoints in Episodic Migraine Study, Demonstrating Treatment Concept After a Single Dose tevapharm.com ↗ |
| 2015-02-24 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Positive Results for TEV-48125 in Phase IIb Chronic Migraine Study Meeting Primary and Secondary Endpoints tevapharm.com ↗ |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 37 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Fremanezumab | “Standard dose of Fremanezumab, 225 mg (Ajovy) injected subcutaneously” NCT07071506 ↗23 |
| Known as | AJOVY | “Assessing the Safety and Efficacy of Utilizing CGRPmAb Fremanezumab (Ajovy) in Chronic Migraine Patients Currently on Monotherapy OnabotulinumtoxinA (Botox).” NCT05724771 ↗3“This study is being conducted to evaluate the efficacy and safety of AJOVY (fremanezumab-vfrm) on interictal migraine related burden in adults.” NCT04461795 ↗ “Fremanezumab (Ajovy) is a month-long-acting anti-CGRP injection that patients are taught to self-administer at home.” NCT04693533 ↗ “Standard dose of Fremanezumab, 225 mg (Ajovy) injected subcutaneously” NCT07071506 ↗ |
| Known as | Fremanezumab-vfrm | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04461795 ↗ |
| Known as | LBR-101 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01991509 ↗ |
| Known as | PF-04472429 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297756 ↗ |
| Known as | RN-307 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297756 ↗ |
| Known as | TEV-48125 | “Fremanezumab (formerly TEV-48125) is a monoclonal antibody directed against calcitonin-gene-related peptide (CGRP), a validated target for migraine preventive therapy.” PMID 28862758 ↗ Sep 20176“The purpose of the current study is to evaluate the efficacy and safety of Fremanezumab (TEV-48125), in the prevention of CCH in adult participants.” NCT02964338 ↗ “A Safety Evaluation Trial of TEV-48125 Self-administered in Migraine Patients” NCT04355117 ↗ |
| Action | Inhibit | “Fremanezumab (Ajovy) is a month-long-acting anti-CGRP injection” NCT04693533 ↗ |
| Modality | Monoclonal antibody | “a selective monoclonal CGRP ligand antibody” PMID 30450545 ↗ Nov 2018 |
| Route | Intravenous | “Administered Intravenously” NCT01991509 ↗ |