Emgality® (Galcanezumab)

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Galcanezumab: Effect on CGRP Levels

Total plasma CGRP levels increased after galcanezumab administration indicating CGRP binds to galcanezumab, reducing free CGRP.


Detailed Information

This medical response may not completely match the information in the current local labeling for GALCANEZUMAB. Please see local labeling for approved label information.

CGRP Plasma Concentration

A drug-tolerant CGRP assay was used in the clinical program for migraine prevention and treatment of episodic cluster headache to measure total CGRP concentrations (total CGRP = galcanezumab-bound CGRP + free CGRP).1,2

When galcanezumab is administered, the premise is that

  • CGRP will bind to galcanezumab, and
  • the amount of free CGRP that is available to interact with the CGRP receptors will be reduced.1,2

Upon galcanezumab administration, galcanezumab-bound CGRP is expected to take on the disposition characteristics of galcanezumab resulting in

  • a lower clearance than free CGRP, and
  • an increase in total CGRP concentration.1,2

In the phase 3 double-blind, placebo-controlled migraine prevention and episodic cluster headache studies,3-6 total CGRP concentrations increased after galcanezumab administration compared to placebo. This indicated that the antibody was

Higher total CGRP concentrations in galcanezumab-treated patients were associated with a greater change from baseline compared to placebo in reduction of

  • monthly migraine headache days for patients with episodic or chronic migraine,2 and
  • episodic cluster headache attack frequency.1
Total CGRP Plasma Mean Concentrations (ng/mL) at End of Double-Blind Treatment in the Phase 3 Migraine Prevention Studies1



GMB 120 mg

GMB 240 mg













Abbreviations: CGRP = calcitonin gene-related peptide; GMB = galcanezumab; PBO = placebo.

aRepresents total CGRP plasma concentrations at month 6.

bRepresents total CGRP plasma concentrations at month 3.

Total CGRP Plasma Mean Concentrations (ng/mL) at End of Double-Blind Treatment in the Episodic Cluster Headache Study1



GMB 300 mg




Abbreviations: CGRP = calcitonin gene-related peptide; GMB = galcanezumab; PBO = placebo.

aRepresents total plasma CGRP concentrations at month 2.


1Data on file, Eli Lilly and Company and/or one of its subsidiaries.

2Kielbasa W, Helton DL. A new era for migraine: Pharmacokinetic and pharmacodynamic insights into monoclonal antibodies with a focus on galcanezumab, an anti-CGRP antibody. Cephalalgia.2019;39(10):1284-1297. http://dx.doi.org/10.1177/0333102419840780

3Stauffer VL, Dodick DW, Zhang Q, et al. Evaluation of galcanezumab for the prevention of episodic migraine: the EVOLVE-1 randomized clinical trial. JAMA Neurol. 2018;75(9):1080-1088. http://dx.doi.org/10.1001/jamaneurol.2018.1212

4Skljarevski V, Matharu M, Millen BA, et al. Efficacy and safety of galcanezumab for the prevention of episodic migraine: results of the EVOLVE-2 phase 3 randomized controlled clinical trial. Cephalalgia. 2018;38(8):1442-1454. http://dx.doi.org/10.1177/0333102418779543

5Detke HC, Goadsby PJ, Wang S, et al. Galcanezumab in chronic migraine: the randomized, double-blind, placebo-controlled REGAIN study. Neurology. 2018;91(24):e2211-e2221. http://dx.doi.org/10.1212/WNL.0000000000006640

6Goadsby PJ, Dodick DW, Leone M, et al. Trial of galcanezumab in prevention of episodic cluster headache. N Engl J Med. 2019;381(2):132-141. http://dx.doi.org/10.1056/NEJMoa1813440


CGRP = calcitonin gene-related peptide

Fecha de la última revisión: 2020 M02 06

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