Drugs / Galcanezumab
Galcanezumab
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | EMGALITY | — | 2019-06-04 | fda.gov ↗ |
| Approved | EU (EMA) | Emgality | — | 2018-11-14 | europa.eu ↗ |
| Approved | US (FDA) | EMGALITY | — | 2018-09-27 | fda.gov ↗ |
Trials 31 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT07323927 | Aug 2025 → Jan 2027 expected | Alzheimer disease | Xuanwu Hospital, Beijing | Recruiting | No outcome recorded |
| Phase 16 trials | ||||||
| Phase 1 | NCT04085289 | Nov 2019 → May 2020 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT04179474 | Sep → Dec 2019 | migraine disorder | Allergan | Completed | No outcome recorded |
| Phase 1 | NCT02836613 | Jul 2016 → Feb 2017 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT02576951 | Oct 2015 → Sep 2016 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT02104765 | Jun 2014 → Jan 2015 | migraine disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01337596 | Apr 2011 → Apr 2012 | migraine disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 25 trials | ||||||
| Phase 2 | NCT04417361 | Sep 2020 → Sep 2023 | migraine disorder | University of California, San Francisco | Completed | No outcome recorded |
| Phase 2 | NCT02959177 | Nov 2016 → Jan 2019 | migraine disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT02163993 | Jul 2014 → Aug 2015 | migraine disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT02192190 | Jul 2014 → Apr 2015 | osteoarthritis, knee | Eli Lilly and Company | Terminated | No outcome recorded |
| Phase 2 | NCT01625988 | Jun 2012 → Jul 2013 | migraine disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 312 trials | ||||||
| Phase 3 | NCT04616326 | Nov 2020 → Dec 2025 overdue | migraine disorder | Eli Lilly and Company | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03963232 | Jul 2019 → Jul 2021 | migraine disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT03559257 | Jul 2018 → Jun 2019 | migraine disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT03432286 | Mar 2018 → Nov 2025 overdue | migraine disorder | Eli Lilly and Company | Active not recruiting | No outcome recorded |
| Phase 3 | NCT02959190 | Feb 2017 → Aug 2019 | migraine disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT02797951 | Jul 2016 → Jan 2021 | cluster headache syndrome | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT02614196 | Dec 2015 → Mar 2017 | migraine disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT02614183 | Nov 2015 → Mar 2017 | migraine disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT02614287 | Nov 2015 → May 2017 | migraine disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT02614261 | Nov 2015 → Mar 2017 | migraine disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT02438826 | Jun 2015 → Mar 2018 | cluster headache syndrome | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT02397473 | May 2015 → Feb 2018 | cluster headache syndrome | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 47 trials | ||||||
| Phase 4 | NCT07655440 | Jul 2026 → Jul 2031 expected | migraine disorder, tinnitus, vestibular disorder | Stanford University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05284019 | Mar 2022 → Feb 2023 | migraine disorder | H. Lundbeck A/S | Terminated | No outcome recorded |
| Phase 4 | NCT05127486 | Dec 2021 → May 2023 | migraine disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 4 | NCT04294147 | Oct 2020 → Mar 2021 | migraine disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 4 | NCT06901518 | Aug 2020 → Jun 2024 | traumatic encephalopathy | Albany Medical College | Completed | No outcome recorded |
| Phase 4 | NCT04271202 | Jul 2020 → Nov 2023 | migraine disorder | Beth Israel Deaconess Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT04158752 | Jul 2020 → Jan 2023 | glossopharyngeal neuralgia, trigeminal neuralgia | Duke University | Completed | No outcome recorded |
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 4 | NCT05492695 Comparator | Oct 2022 → Sep 2023 | migraine disorder | Diamond Headache Clinic | Terminated | No outcome recorded |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 37 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Galcanezumab | “Galcanezumab effects on incidence of headache after occurrence of triggers, premonitory symptoms, and aura in responders, non-responders, super-responders, and super non-responders.” PMID 36927366 ↗ Mar 202328“Galcanezumab is a humanized immunoglobulin G (IgG) monoclonal antibody (mAb) indicated for the prevention of migraine that binds to calcitonin gene-related peptide.” PMID 31482569 ↗ Sep 2019 “Galcanezumab” NCT04271202 ↗ |
| Known as | Emgality | ChEMBL registry synonym — accepted as the source's own label CHEMBL3707328 ↗ |
| Known as | Galcanezumab-Gnlm | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06901518 ↗ |
| Known as | LY2951742 | “Single dose of 240 milligrams (mg) galcanezumab (LY2951742) administered subcutaneously (SC) by manual prefilled syringe (PFS).” NCT02836613 ↗5“A Study of Galcanezumab (LY2951742) in Adult Participants With Episodic Migraine” NCT05127486 ↗ |
| Action | Inhibit | “inhibits its biological activity” PMID 32050782 ↗ Feb 2020 |
| Modality | Monoclonal antibody | “LY2951742, a fully humanised monoclonal antibody to calcitonin gene-related peptide” PMID 25127173 ↗ Aug 2014 |
| Route | Subcutaneous | “Administered subcutaneously” NCT01337596 ↗ |