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
| 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 · 4 met primary · 1 missed | ||||||
| Phase 2 | NCT04417361 | Sep 2020 → Sep 2023 | migraine disorder | University of California, San Francisco | Completed | Met primary |
| Phase 2 | NCT02959177 | Nov 2016 → Jan 2019 | migraine disorder | Eli Lilly and Company | Completed | Met primary |
| Phase 2 | NCT02163993 | Jul 2014 → Aug 2015 | migraine disorder | Eli Lilly and Company | Completed | Met primary |
| Phase 2 | NCT02192190 | Jul 2014 → Apr 2015 | osteoarthritis, knee | Eli Lilly and Company | Terminated | Missed primary |
| Phase 2 | NCT01625988 | Jun 2012 → Jul 2013 | migraine disorder | Eli Lilly and Company | Completed | Met primary |
| Phase 312 trials · 6 met primary · 1 missed | ||||||
| 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 | Met primary |
| Phase 3 | NCT03559257 | Jul 2018 → Jun 2019 | migraine disorder | Eli Lilly and Company | Completed | Met primary |
| 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 | Met primary |
| Phase 3 | NCT02614183 | Nov 2015 → Mar 2017 | migraine disorder | Eli Lilly and Company | Completed | Met primary |
| 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 | Met primary |
| Phase 3 | NCT02438826 | Jun 2015 → Mar 2018 | cluster headache syndrome | Eli Lilly and Company | Completed | Missed primary |
| Phase 3 | NCT02397473 | May 2015 → Feb 2018 | cluster headache syndrome | Eli Lilly and Company | Completed | Met primary |
| Phase 47 trials · 1 missed | ||||||
| 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 | Missed primary |
| 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 |
| Comparator or background therapy1 trial | ||||||
| Phase 4 | NCT05492695 Comparator | Oct 2022 → Sep 2023 | migraine disorder | Diamond Headache Clinic | Terminated | No outcome recorded Stop: Enrollment |
News releases announcing trial results or a regulatory action · 22
| Date | Issuer | Release |
|---|---|---|
| 2023-06-16 | Eli Lilly and Company | Results First-Of-Its-Kind Head-to-Head Clinical Trial Reaffirms the Efficacy of Emgality in Episodic Migraine Prevention lilly.com ↗
Emgality did not meet the study's primary endpoint, defined as statistical superiority to Nurtec ODT on the percentage of participants achieving a 50% or greater reduction in monthly migraine headache days. |
| 2021-06-03 | Eli Lilly and Company | Results Lilly Reveals Critical Barriers to Optimal Migraine Care and Insights From Novel Clinical and Patient-Centric Real-World Evidence, Supporting Lilly's Preventive and Acute Treatment Portfolio at AHS 2021 lilly.com ↗
greater adherence and persistence for Emgality® (galcanezumab-gnlm), a calcitonin gene-related peptide monoclonal antibody (CGRP mAb), compared to oral standard of care (non-CGRP mAb) preventive migraine treatments in a healthcare claims study |
| 2020-06-17 | Eli Lilly and Company | Results Emgality® Demonstrates Reduction in Frequency, Duration, and Pain Severity in Patients with Episodic and Chronic Migraine lilly.com ↗
Emgality® (galcanezumab-gnlm) reduces total pain burden in a recent analysis of patients with episodic and chronic migraine. |
| 2020-05-26 | Eli Lilly and Company | Results Emgality® Shows Improvement in Work Productivity and Health and Well-Being Between Attacks in Patients with Migraine and a History of Preventive Treatment Failure lilly.com ↗
Emgality® (galcanezumab-gnlm) significantly improved work productivity and reduced interictal burden, defined as health and well-being between migraine attacks, in an analysis of the 3-month double-blind period of the CONQUER study, which included patients with migraine from 12 different countries. |
| 2019-08-05 | Eli Lilly and Company | Results Lilly Announces Positive Results for Emgality® (galcanezumab-gnlm) from the CONQUER Study in Patients who Failed Previous Migraine Preventive Treatments lilly.com ↗
Emgality® (galcanezumab-gnlm) met the primary and all key secondary outcomes in CONQUER |
| 2019-07-12 | Eli Lilly and Company | Results AHS 2019: Post-Hoc Analyses of Phase 3 Pivotal Studies of Emgality® (galcanezumab-gnlm) Show Improvements in Daily Functioning and Reductions in Disability in Patients with Chronic and Episodic Migraine lilly.com ↗
Eli Lilly and Company (NYSE: LLY) today announced the presentation of post-hoc analyses showing improvements in daily functioning and reductions in disability in patients with chronic and episodic migraine treated with Emgality® (galcanezumab-gnlm) compared to placebo. |
| 2019-07-11 | Eli Lilly and Company | Results New England Journal of Medicine Publishes Positive Phase 3 Data for Emgality® (galcanezumab-gnlm) in Episodic Cluster Headache lilly.com ↗
Eli Lilly and Company (NYSE: LLY) announced today that the New England Journal of Medicine published positive Phase 3 study results of Emgality® (galcanezumab-gnlm) for the treatment of episodic cluster headache. |
| 2019-06-04 | Eli Lilly and Company | Regulatory FDA Approves Emgality® (galcanezumab-gnlm) as the First and Only Medication for the Treatment of Episodic Cluster Headache that Reduces the Frequency of Attacks lilly.com ↗
INDIANAPOLIS, June 4, 2019 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved Emgality® (galcanezumab-gnlm) injection (300 mg) for the treatment of episodic cluster headache in adults. |
| 2019-05-06 | Eli Lilly and Company | Results AAN 2019: Pooled Analyses of Two Emgality® (galcanezumab-gnlm) Phase 3 Studies Show Reduction in Monthly Migraine Headache Days in Low- and High-Frequency Episodic Migraine Subgroups lilly.com ↗
Emgality 120 mg and 240 mg demonstrated a statistically significant reduction in monthly migraine headache days in both the low- and high-frequency subgroups, when compared with placebo. |
| 2019-03-05 | Eli Lilly and Company | Regulatory Lilly Receives FDA Priority Review Designation for Emgality® (galcanezumab-gnlm) Injection for the Preventive Treatment of Episodic Cluster Headache in Adults lilly.com ↗
Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review for its supplemental Biologics License Application (sBLA) for Emgality® (galcanezumab-gnlm) injection for the preventive treatment of episodic cluster headache in adults. |
| 2018-11-14 | Eli Lilly and Company | Regulatory Lilly Submits New Drug Application to the FDA for Lasmiditan for Acute Treatment of Migraine, Receives Breakthrough Therapy Designation for Emgality™ (galcanezumab-gnlm) for Prevention of Episodic Cluster Headache lilly.com ↗
The FDA has granted Breakthrough Therapy Designation to Emgality for episodic cluster headache. |
| 2018-09-27 | Eli Lilly and Company | Regulatory Lilly's Emgality™ (galcanezumab-gnlm) Receives U.S. FDA Approval for the Preventive Treatment of Migraine in Adults lilly.com ↗
Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved Emgality™ (galcanezumab-gnlm) 120 mg injection for the preventive treatment of migraine in adults. |
| 2018-09-21 | Eli Lilly and Company | Regulatory Lilly Receives Positive CHMP Opinion for Emgality™ (galcanezumab) for the Prophylaxis of Migraine in Adults lilly.com ↗
Eli Lilly and Company (NYSE:LLY) announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Emgality™ (galcanezumab) for the prophylaxis of migraine in adults who have at least four migraine days per month. |
| 2018-06-27 | Eli Lilly and Company | Results AHS 2018: Lilly's Emgality™ (galcanezumab-gnlm) Significantly Reduced Monthly Migraine Headache Days in Patients with Migraine Who Previously Failed BOTOX®* (onabotulinumtoxinA) lilly.com ↗
INDIANAPOLIS, June 27, 2018 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today results from a post-hoc analysis which demonstrated efficacy of Emgality™ (galcanezumab-gnlm) in patients with episodic and chronic migraine who had previously failed preventive treatment with BOTOX®* (onabotulinumtoxinA). |
| 2018-06-27 | Eli Lilly and Company | Results AHS 2018: Lilly Highlights Positive Phase 3 Results from the Largest Controlled Preventive Trial in Episodic Cluster Headache lilly.com ↗
Eli Lilly and Company (NYSE:LLY) announced today full results from a positive Phase 3 study of patients with episodic cluster headache treated with Emgality™ (galcanezumab-gnlm). |
| 2018-05-15 | Eli Lilly and Company | Results Lilly's Galcanezumab Meets Primary Endpoint in Phase 3 Study Evaluating Galcanezumab for the Prevention of Episodic Cluster Headache lilly.com ↗
A statistically significantly greater percentage of patients treated with galcanezumab also achieved at least a 50 percent reduction in weekly cluster headache attacks compared to placebo at Week 3, the gated secondary endpoint. |
| 2018-04-24 | Eli Lilly and Company | Results AAN 2018: Lilly's Galcanezumab Significantly Reduced Monthly Migraine Headache Days in Patients with Migraine Who Previously Failed to Respond to Multiple Preventive Therapies lilly.com ↗
Eli Lilly and Company (NYSE: LLY) announced today results from a post-hoc subgroup analysis which demonstrated efficacy of galcanezumab in patients with episodic and chronic migraine who previously failed to respond to two or more preventive therapies. |
| 2017-12-11 | Eli Lilly and Company | Regulatory FDA Accepts Biologics License Application (BLA) to Review Galcanezumab for the Prevention of Migraine in Adults lilly.com ↗
Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) to review galcanezumab for the prevention of migraine in adults. |
| 2017-09-08 | Eli Lilly and Company | Results IHC 2017: Lilly's Galcanezumab Demonstrates Positive Long-Term Safety Results for up to 12 Months in Patients with Migraine lilly.com ↗
INDIANAPOLIS, Sept. 8, 2017 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that treatment with self-administered galcanezumab for up to 12 months demonstrated a positive safety and tolerability profile in patients with migraine, consistent with previous studies. |
| 2017-06-10 | Eli Lilly and Company | Results Lilly's Galcanezumab Significantly Reduces Number of Migraine Headache Days for Patients with Migraine: New Results Presented at AHS lilly.com ↗
The observed safety and tolerability profile was consistent with findings from previous studies of galcanezumab. |
| 2017-05-12 | Eli Lilly and Company | Results Lilly Announces Positive Results for Three Phase 3 Studies of Galcanezumab for the Prevention of Episodic and Chronic Migraine lilly.com ↗
In these three studies, the most commonly-reported adverse events were injection site reactions, including pain. |
| 2015-06-17 | Eli Lilly and Company | Results Lilly's investigational medicine for prevention of migraine met primary endpoint in a Phase 2b study lilly.com ↗
LY2951742 demonstrated a statistically significant reduction in migraine headache days and a safety and tolerability profile confirming the previous results seen in a Phase 2a study. |
All press releases naming this drug 29 releases
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 ↗ |