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galcanezumab

Generic: galcanezumab·Brand: Emgality

galcanezumab: sourced relationships with 1 company · 3 clinical trials tracked · 1 FDA decision.

galcanezumab evidence translation

What we can confirm

1 FDA record · 3 tracked trials

What it means

Source-backed records connect galcanezumab to LLY; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could galcanezumab → LLY affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence4 indications · 0 study sponsors

Related indications

For migraine prevention and the treatment of episodic cluster headache in adults.Chronic MigraineMigraineOveractive Bladder

Study sponsors

No additional listed-company sponsor is linked.

Dated Pipeline Records (1)
CompanyDated record stage
ELI LILLY & Co (LLY)
Reported 2018-09-27 · Current development: unknownSource
For migraine prevention and the treatment of episodic cluste…
Approved
Clinical Trial Registry Records (3)

Migraine Medication Effects on Urinary Symptoms

NCT06212661Registry updated 2025-10-01
Enrolling by invitation

Primary endpoint: changes in OAB symptoms

Observational200 targetStarted 2024-04Completion 2026-121 site · United StatesThe Cleveland Clinic

Prospective Evaluation of Emgality (Galcanezumab) in Breastmilk in Adult Women With Migraine

NCT06085144Registry updated 2026-08-11
Recruiting

Primary endpoint: Determine emgality concentration in mature breastmilk

Observational30 targetStarted 2024-02Completion 2028-041 site · United StatesUniversity of California, San Francisco

A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Adolescent Patients 12 to 17 Years of Age With Chronic Migraine - the REBUILD-2 Study

NCT04616326Registry updated 2026-02-27·Phase 3
Active, not recruiting

Primary endpoint: Change from Baseline in the Number of Monthly Migraine Headache Days

InterventionalRandomizeddouble312 targetStarted 2020-11Completion 2027-0350 sites · Denmark, France, United StatesEli Lilly and Company
FDA Decisions1 records
Approval1 INDICATIONS AND USAGE EMGALITY ® is a calcitonin-gene related peptide antagonist indicated in adults for the: preventive treatment of migraine. ( 1.1 ) treatment of episodic cluster headache. ( 1.2 ) 1.1 Migraine EMGALITY is indicated for the preventive treatment of migraine in adults. 1.2 Episodic Cluster Headache EMGALITY is indicated for the treatment of episodic cluster headache in adults.(LLY)FDA ↗
BLA761063Type 1 - New Molecular EntityStandardOtherInjectable

Frequently asked questions

Which companies have sourced relationships with galcanezumab?

galcanezumab has dated SEC/FDA relationship records for ELI LILLY & Co.

How many clinical trials involve galcanezumab?

BioSniper tracks 3 clinical trials involving galcanezumab.

What is galcanezumab's latest FDA decision?

The most recent tracked FDA decision for galcanezumab is Approval for 1 INDICATIONS AND USAGE EMGALITY ® is a calcitonin-gene related peptide antagonist indicated in adults for the: preventive treatment of migraine. ( 1.1 ) treatment of episodic cluster headache. ( 1.2 ) 1.1 Migraine EMGALITY is indicated for the preventive treatment of migraine in adults. 1.2 Episodic Cluster Headache EMGALITY is indicated for the treatment of episodic cluster headache in adults., dated September 27, 2018.