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Drug

Galcanezumab

Approved medicine
ClassCalcitonin gene-related peptide inhibitorResearchOngoing clinical research

Also known as Emgality.

RxNorm2058846ChEMBLCHEMBL3707328ATCN02CD02UNII55KHL3P693
4
Active clinical trials
2
Protein targets
7
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Comparative Outcomes of Migraine Preventives and Anti-CGRP Therapies for Tinnitus in Patients With Migraine: A Randomized Active-Comparator Controlled Trial (COMPACT-PM)

Clinical trial2026-06-17Results expected Q3 2031 · ClinicalTrials.gov

Label change: GALCANEZUMAB-GNLM (BLA761063)

Regulatory2026-06-05FDA

Anti-CGRP Neutralizing Antibody for Modulation of Neurogenic Inflammation in Trigeminal and Glossopharyngeal Pain Associated With Small Fiber Neuropathy/Fibromyalgia

Clinical trial2026-02-02Results posted · ClinicalTrials.gov

An Investigator Initiated Trial Evaluating the Therapeutic Efficacy of Galcanezumab in Patients With Alzheimer's Disease

Clinical trial2026-01-07Results expected Q1 2027 · ClinicalTrials.gov

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

Clinical trial2025-12-10Primary completion · ClinicalTrials.gov

A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Patients 6 to 17 Years of Age With Episodic Migraine - the REBUILD-1 Study

Clinical trial2025-11-14Primary completion · ClinicalTrials.gov

Label change: GALCANEZUMAB-GNLM (BLA761063)

Regulatory2025-03-21FDA

A Phase 4, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Galcanezumab Versus Rimegepant in Adult Participants With Episodic Migraine

Clinical trial2024-06-28Results posted · ClinicalTrials.gov

TOGETHER STUDY: Tandem OnabotulinumtoxinA Galcanezumab Emerging Therapeutic Headache Elimination Research Study

Clinical trial2023-09-28Terminated · ClinicalTrials.gov

An Exploratory, Prospective, Randomized, Pragmatic Open Label Cohort Study to Evaluate the Comparative Effectiveness of Eptinezumab in the United States

Clinical trial2023-04-14Terminated · ClinicalTrials.gov

Label change: GALCANEZUMAB-GNLM (BLA761063)

Regulatory2022-05-24FDA

Label change: GALCANEZUMAB-GNLM (BLA761063)

Regulatory2019-12-05FDA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Galcanezumab
Aliases & brands
Emgality
RxNorm CUI
2058846
ChEMBL ID
CHEMBL3707328
ATC codes
N02CD02
UNII
55KHL3P693
Primary mechanism
Calcitonin gene-related peptide inhibitor
Regulatory jurisdictions
emafda

Pharmacology & targets

2 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

Calcitonin gene-related peptide 1
CALCA · P06881
INHIBITORCalcitonin gene-related peptide inhibitor
Calcitonin gene-related peptide 2
CALCB · P10092
INHIBITORCalcitonin gene-related peptide inhibitor

Regulatory timeline

7 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Approval / market entry confirmed across FDA and EMA (2018-09-27 → 2019-06-04)
Earliest approval
2018-09-27
Latest approval
2019-06-04
Authorities
FDA · EMA
Total events
7
fdaU.S. Food and Drug Administration· 6 events
2026-06-05Label change
Label change: GALCANEZUMAB-GNLM (BLA761063)
Evidence ↗
2025-03-21Label change
Label change: GALCANEZUMAB-GNLM (BLA761063)
Evidence ↗
2022-05-24Label change
Label change: GALCANEZUMAB-GNLM (BLA761063)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2018-11-14ApprovalMulti-authority
Approval: Emgality (EMA)

Indication: Emgality is indicated for the prophylaxis of migraine in adults who have at least 4 migraine days per month.

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

25 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
25
registered trials across all phases
LATEST COMPLETION 2023
4
Active studies
2
Recruiting
18
Late-stage (III+)
19
Completed
2
Discontinued
PHASE DISTRIBUTIONn = 25
Early Phase 11Phase 14Phase 22Phase 312Phase 46

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Comparative Outcomes of Migraine Preventives and Anti-CGRP Therapies for Tinnitus in Patients With Migraine: A Randomized Active-Comparator Controlled Trial (COMPACT-PM)

Not yet recruitingPH IVStanford Universityn=1202031

TOGETHER STUDY: Tandem OnabotulinumtoxinA Galcanezumab Emerging Therapeutic Headache Elimination Research Study

TerminatedPH IVDiamond Headache Clinicn=22023

A Phase 4, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Galcanezumab Versus Rimegepant in Adult Participants With Episodic Migraine

CompletedPH IVEli Lilly and Companyn=5802023

An Exploratory, Prospective, Randomized, Pragmatic Open Label Cohort Study to Evaluate the Comparative Effectiveness of Eptinezumab in the United States

TerminatedPH IVH. Lundbeck A/Sn=322023

Anti-CGRP Neutralizing Antibody for Modulation of Neurogenic Inflammation in Trigeminal and Glossopharyngeal Pain Associated With Small Fiber Neuropathy/Fibromyalgia

CompletedPH IVDuke Universityn=262023

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase 4, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Galcanezumab Versus Rimegepant in Adult Participants With Episodic Migraine

CompletedPH IVEli Lilly and Companyn=5802023

Anti-CGRP Neutralizing Antibody for Modulation of Neurogenic Inflammation in Trigeminal and Glossopharyngeal Pain Associated With Small Fiber Neuropathy/Fibromyalgia

CompletedPH IVDuke Universityn=262023

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Galcanezumab in Patients With Episodic Migraine-the Persist Study

CompletedPH IIIEli Lilly and Companyn=5202022

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 in Patients With Chronic Migraine - the REGAIN Study

CompletedPH IIIKey trialEli Lilly and Companyn=1,1172021

A Phase 4 Single-Blind Study of Gastrointestinal Transit Time in Adult Patients With Migraine Before and After Initiation of a mAb CGRP Antagonist

CompletedPH IVEli Lilly and Companyn=652021

A Phase 3b Multicenter, Single-Arm, Open-Label Safety Study of LY2951742 (Galcanezumab) in Patients With Episodic or Chronic Cluster Headache

CompletedPH IIIEli Lilly and Companyn=1652021
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.