Drugs / Eptinezumab
Eptinezumab
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed migraine disorder 3 milestones | |||||
| Filed | EU (EMA) | VYEPTI | migraine disorder | — | “The European Medicines Agency (EMA) is currently reviewing the marketing authorization application for VYEPTI.” lundbeck.com ↗ |
| Filed | Other | VYEPTI | migraine disorder | — | “Lundbeck has submitted an application for market authorization of VYEPTI in Canada” lundbeck.com ↗ |
| Filed | US (FDA) | — | migraine disorder | — | “Alder submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for eptinezumab in February 2019” lundbeck.com ↗ “Alder submitted a Biologics License Application (BLA) to the FDA for eptinezumab in February 2019” lundbeck.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | EU (EMA) | Vyepti | — | 2022-01-24 | europa.eu ↗ |
Trials 28
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials | ||||||
| Phase 1 | NCT05074459 | Sep 2021 → Jul 2022 | — | H. Lundbeck A/S | Completed | No outcome recorded |
| Phase 1 | NCT05045781 | Apr → Jul 2021 | — | H. Lundbeck A/S | Completed | No outcome recorded |
| Phase 1 | NCT04537429 | Aug 2020 → Oct 2022 | migraine disorder | H. Lundbeck A/S | Completed | No outcome recorded |
| Phase 1 | NCT04336449 | Apr → Aug 2020 | — | H. Lundbeck A/S | Completed | No outcome recorded |
| Phase 1 | NCT01772524 | Jan → Dec 2013 | migraine disorder | Alder Biopharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01579383 | Apr → Dec 2012 | migraine disorder | Alder Biopharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 22 trials · 1 met primary | ||||||
| Phase 2 | NCT05937152 | Jan → Nov 2025 | diabetic polyneuropathy | Mayo Clinic | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02275117 | Oct 2014 → Mar 2016 | migraine disorder | Alder Biopharmaceuticals, Inc. | Completed | Met primary |
| Phase 316 trials · 5 met primary · 2 missed | ||||||
| Phase 3 | NCT07645833 | Jun 2026 → Jun 2028 expected | pseudotumor cerebri | Rigmor Højland Jensen | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07191145 | Jan 2026 → Jun 2027 expected | traumatic encephalopathy | Sunnybrook Health Sciences Centre | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06428838 | May 2025 → Mar 2028 expected | migraine disorder | Dr George Medvedev | Enrolling by invitation | No outcome recorded |
| Phase 3 | NCT05897320 | Jun 2023 → Jul 2027 expected | migraine disorder | H. Lundbeck A/S | Recruiting | No outcome recorded |
| Phase 3 | NCT05164172 | Dec 2021 → Apr 2028 expected | migraine disorder | H. Lundbeck A/S | Recruiting | No outcome recorded |
| Phase 3 | NCT05064371 | Sep 2021 → Jun 2024 | migraine disorder | H. Lundbeck A/S | Completed | No outcome recorded |
| Phase 3 | NCT05064397 | Sep 2021 → Jun 2023 | cluster headache syndrome | H. Lundbeck A/S | Completed | No outcome recorded |
| Phase 3 | NCT04965675 | Jun 2021 → Sep 2026 overdue | — | H. Lundbeck A/S | Recruiting | No outcome recorded |
| Phase 3 | NCT04921384 | May 2021 → Oct 2024 | migraine disorder | H. Lundbeck A/S | Completed | Met primary |
| Phase 3 | NCT04772742 | Feb 2021 → May 2022 | migraine disorder | H. Lundbeck A/S | Completed | Missed primary |
| Phase 3 | NCT04688775 | Dec 2020 → Jun 2023 | cluster headache syndrome | H. Lundbeck A/S | Completed | Missed primary |
| Phase 3 | NCT04418765 | Jun 2020 → Jul 2021 | migraine disorder | H. Lundbeck A/S | Completed | Met primary |
| Phase 3 | NCT04152083 | Nov 2019 → Jul 2020 | migraine disorder | H. Lundbeck A/S | Completed | Met primary |
| Phase 3 | NCT02985398 | Dec 2016 → Apr 2018 | migraine disorder | Alder Biopharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02974153 | Nov 2016 → Nov 2017 | migraine disorder | Alder Biopharmaceuticals, Inc. | Completed | Met primary |
| Phase 3 | NCT02559895 | Sep 2015 → Feb 2017 | migraine disorder | Alder Biopharmaceuticals, Inc. | Completed | Met primary |
| Phase 44 trials · 1 met primary | ||||||
| Phase 4 | NCT07655440 | Jul 2026 → Jul 2031 expected | migraine disorder, tinnitus, vestibular disorder | Stanford University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06701526 | Dec 2024 → Sep 2026 | migraine disorder | H. Lundbeck A/S | Completed | No outcome recorded |
| Phase 4 | NCT05452239 | Jul 2022 → Oct 2024 | migraine disorder | H. Lundbeck A/S | Completed | Met primary |
| Phase 4 | NCT05284019 | Mar 2022 → Feb 2023 | migraine disorder | H. Lundbeck A/S | Terminated | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| — | NCT05635604 Comparator | Mar → Aug 2023 | migraine disorder | Danish Headache Center | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 19
| Date | Issuer | Release |
|---|---|---|
| 2026-10-01 | H. Lundbeck A/S | Results Lundbeck announces headline results from Phase IV THRIVE trial evaluating VYEPTI® (eptinezumab) following inadequate response to prior CGRP-targeting preventive therapy lundbeck.com ↗
Primary endpoint analysis of the clinical Phase IV THRIVE trial showed that 60% of participants reported being ‘much improved’ or ‘very much improved’ following treatment with eptinezumab |
| 2026-06-04 | H. Lundbeck A/S | Results Lundbeck Presents New VYEPTI® (eptinezumab-jjmr) and Bocunebart Migraine Data at the American Headache Society 68th Annual Scientific Meeting lundbeck.com ↗
New 12-month data from the INFUSE study show patient-reported outcomes related to multiple migraine-related cognitive symptoms in participants who failed at least one prior calcitonin gene-related peptide (CGRP)-targeted therapy1 |
| 2026-04-19 | H. Lundbeck A/S | Results Lundbeck presents new data at AAN 2026 highlighting real-world changes in migraine-related cognitive symptoms after starting VYEPTI® (eptinezumab-jjmr) lundbeck.com ↗
These patient-reported outcomes data highlight the opportunity to focus on elements of migraine burden that are meaningful to individuals living with migraine and report improvement of migraine-related cognitive symptoms after VYEPTI® (eptinezumab-jjmr) treatment. |
| 2026-01-30 | H. Lundbeck A/S | Results Lundbeck presents new real-world data highlighting meaningful improvements in patients severely impacted by migraine initiating Vyepti® (eptinezumab), at HCOP Annual Conference lundbeck.com ↗
The findings, presented at the 2026 Headache Cooperative of the Pacific (HCOP) Annual Conference in California, USA (30–31 January), show improvements across multiple patient-reported outcomes in patients switching to intravenous (IV) eptinezumab, despite high disease burden.1 |
| 2025-06-19 | H. Lundbeck A/S | Results Lundbeck advances leadership in migraine with new data at the American Headache Society 67th Annual Scientific Meeting lundbeck.com ↗
In a post-hoc analysis of the DELIVER trial, interictal periods were longer with VYEPTI compared to placebo and corresponded to higher patient-reported quality of life outcomes |
| 2024-06-13 | H. Lundbeck A/S | Results Lundbeck to Present a Breadth of Migraine and Cluster Headache Data at the 66th Annual Scientific Meeting of the American Headache Society lundbeck.com ↗
Study results showed patients on VYEPTI self-reported a doubling of “good” days per month, and 86% of patients on VYEPTI reported improvements in brain fog after treatment |
| 2024-04-09 | H. Lundbeck A/S | Results Lundbeck to Present Data on Migraine Impact Reduction and Sustained Response with VYEPTI® (eptinezumab-jjmr) at 76th Annual Meeting of the American Academy of Neurology lundbeck.com ↗
Additionally, of the patients with ≥50% response over the first two dosing intervals (weeks 1-24), 82% of patients (107/131) taking VYEPTI 300 mg maintained their response over the study duration.1 |
| 2023-06-15 | H. Lundbeck A/S | Results Lundbeck to Present New Clinical and Real-World VYEPTI® (eptinezumab-jjmr) Data at the 65th Annual Scientific Meeting of the American Headache Society, Reinforcing Its Use in Migraine Prevention lundbeck.com ↗
First-time presentation of a real-world evidence study that revealed high overall satisfaction with the effectiveness of VYEPTI treatment for chronic migraine among most patients and their treating neurologists, as well as positive infusion experience |
| 2022-06-16 | H. Lundbeck A/S | Results Results from the DELIVER study with VYEPTI® (eptinezumab-jjmr) has been published in a top-ranking medical journal lundbeck.com ↗
The primary and key secondary results on VYEPTI® (eptinezumab-jjmr) from the DELIVER study in patients with migraine and prior preventive treatment failures are now published in the high-impact medical journal Lancet Neurology. |
| 2022-06-09 | H. Lundbeck A/S | Results Lundbeck to Present Data on VYEPTI® (eptinezumab-jjmr) at the 64th Annual Scientific Meeting of the American Headache Society, Furthering Clinical and Real-World Evidence for Migraine Prevention lundbeck.com ↗
Results from new subpopulation analysis of the Phase 3b DELIVER study support the efficacy and safety profile of eptinezumab |
| 2022-04-02 | H. Lundbeck A/S | Results Lundbeck to Present New Data at AAN 2022 Adding to Clinical Evidence Regarding VYEPTI lundbeck.com ↗
Oral presentation of post hoc analysis of PROMISE 2 data suggests that improving to 4 or fewer monthly headache days may be a useful treatment goal for people with chronic migraine |
| 2021-12-13 | H. Lundbeck A/S | Results Lundbeck reports positive results for VYEPTI® (eptinezumab-jjmr) from the DELIVER study in patients with migraine and prior preventive treatment failures lundbeck.com ↗
The study met its primary objective of demonstrating superiority of VYEPTI versus placebo in reducing the number of monthly migraine headache days (MMDs) over 12 weeks of treatment. |
| 2021-06-15 | H. Lundbeck A/S | Results The Journal of the American Medical Association Publishes Data on Efficacy and Safety of Preventive Migraine Treatment VYEPTI® (eptinezumab-jjmr) When Administered During an Active Migraine Attack lundbeck.com ↗
VYEPTI® (eptinezumab-jjmr) met both co-primary endpoints, showing early benefit for time to headache pain freedom, and time to the absence of most bothersome symptoms (MBS), compared to placebo. |
| 2021-04-20 | H. Lundbeck A/S | Results New Data Presented at 2021 American Academy of Neurology (AAN) Annual Meeting Shows VYEPTI® (eptinezumab-jjmr) Demonstrated Earlier Time to Freedom from Headache Pain and Absence of Most Bothersome Symptoms Compared to Placebo When Initiated During Migraine Attack in Patients Who Were Candidates for Preventive Therapy lundbeck.com ↗
Patients receiving VYEPTI reported a median time to headache pain freedom of 4 hours versus 9 hours among those who received placebo and a median time of 2 hours to the absence of their MBS versus 3 hours with placebo. |
| 2020-08-31 | H. Lundbeck A/S | Results Positive headline results from the Vyepti (eptinezumab-jjmr) RELIEF study lundbeck.com ↗ |
| 2020-06-13 | H. Lundbeck A/S | Results AHS Posters for Lundbeck’s VYEPTI™ (eptinezumab-jjmr) in Migraine Prevention Evaluated Early Onset of Action and Reduction in Medication-Overuse Headache lundbeck.com ↗
The post-hoc findings from the pivotal studies (PROMISE 1 in episodic migraine and PROMISE 2 in chronic migraine) further support VYEPTI as a preventive treatment for migraine disease with onset of action day 1 after administration. |
| 2020-03-25 | H. Lundbeck A/S | Results VYEPTI™ (eptinezumab-jjmr) Demonstrated Significant Positive Impact in Prevention of Chronic Migraine in Adults, Pivotal Phase III Study Published in Neurology Finds lundbeck.com ↗
The study demonstrated that use of VYEPTI™ (eptinezumab-jjmr) as a preventive treatment for chronic migraine in adults significantly reduced the number of mean MMD over months 1-3 (primary endpoint). |
| 2020-02-21 | H. Lundbeck A/S | Regulatory FDA approves Lundbeck’s VYEPTI™ (eptinezumab-jjmr) – the first and only intravenous preventive treatment for migraine lundbeck.com ↗
Lundbeck today announced that VYEPTI™ (eptinezumab-jjmr) has been approved by the U.S. Food and Drug Administration (FDA) for the preventive treatment of migraine in adults and will be available in April 2020. |
| 2015-06-24 | Nxera Pharma UK Limited | Results Download the presentation nxera.life ↗
Efficacy demonstrated in chronic migraine prophylaxis with TEV-48125 and ALD403 |
All press releases naming this drug 21 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 33 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | eptinezumab | “repeat intravenous (IV) doses of the calcitonin gene-related peptide‒targeted monoclonal antibody eptinezumab (ALD403) for migraine prevention in adults with episodic migraine.” PMID 33250209 ↗ Nov 202026“We evaluated eptinezumab, an intravenous (IV) anti-calcitonin gene-related peptide monoclonal antibody, for the prevention of chronic migraine.” PMID 31234642 ↗ Jun 2019 “ALD403 (Eptinezumab)” NCT02985398 ↗ |
| Known as | ALD403 | “Eptinezumab or ALD403 is a humanized anti-calcitonin gene-related peptide IgG1 monoclonal antibody that binds to calcitonin gene-related peptide (CGRP).” NCT05635604 ↗6“calcitonin gene-related peptide-targeted monoclonal antibody eptinezumab (ALD403) for migraine prevention” PMID 33023473 ↗ Oct 2020 |
| Known as | Eptinezumab jjmr | ChEMBL registry synonym — accepted as the source's own label CHEMBL3833320 ↗ |
| Known as | Vyepti | “The purpose of the study is to investigate how a medication called eptinezumab (Vyepti) given to patients in the Emergency Department (ED) might help prevent migraines from...” NCT06428838 ↗ |
| Action | Inhibit | “anti-calcitonin gene-related peptide” PMID 31234642 ↗ Jun 2019 |
| Modality | Monoclonal antibody | “a Humanized Anti-Calcitonin Gene-Related Peptide Monoclonal Antibody” NCT01579383 ↗ |
| Route | Intravenous | “Administered by Intravenous Infusion” NCT01579383 ↗ |