Drugs / Eptinezumab
Eptinezumab
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Vyepti | — | 2022-01-24 | europa.eu ↗ |
Trials 28 · a red edge is where a trial was stopped
| 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 | ||||||
| Phase 2 | NCT05937152 | Jan → Nov 2025 | diabetic polyneuropathy | Mayo Clinic | Withdrawn | No outcome recorded |
| Phase 2 | NCT02275117 | Oct 2014 → Mar 2016 | migraine disorder | Alder Biopharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 316 trials | ||||||
| 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 | Sep 2024 → Dec 2025 | migraine disorder | Dr George Medvedev | Unknown | 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 expected | — | H. Lundbeck A/S | Recruiting | No outcome recorded |
| Phase 3 | NCT04921384 | May 2021 → Oct 2024 | migraine disorder | H. Lundbeck A/S | Completed | No outcome recorded |
| Phase 3 | NCT04772742 | Feb 2021 → May 2022 | migraine disorder | H. Lundbeck A/S | Completed | No outcome recorded |
| Phase 3 | NCT04688775 | Dec 2020 → Jun 2023 | cluster headache syndrome | H. Lundbeck A/S | Completed | No outcome recorded |
| Phase 3 | NCT04418765 | Jun 2020 → Jul 2021 | migraine disorder | H. Lundbeck A/S | Completed | No outcome recorded |
| Phase 3 | NCT04152083 | Nov 2019 → Jul 2020 | migraine disorder | H. Lundbeck A/S | Completed | No outcome recorded |
| 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 | No outcome recorded |
| Phase 3 | NCT02559895 | Sep 2015 → Feb 2017 | migraine disorder | Alder Biopharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 44 trials | ||||||
| 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 → Jun 2026 overdue | migraine disorder | H. Lundbeck A/S | Active not recruiting | No outcome recorded |
| Phase 4 | NCT05452239 | Jul 2022 → Oct 2024 | migraine disorder | H. Lundbeck A/S | Completed | No outcome recorded |
| Phase 4 | NCT05284019 | Mar 2022 → Feb 2023 | migraine disorder | H. Lundbeck A/S | Terminated | No outcome recorded |
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| — | NCT05635604 Comparator | Mar → Aug 2023 | migraine disorder | Danish Headache Center | Completed | No outcome recorded |
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 ↗ |