Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 95 |
| INN | Galcanezumab |
| Status | Approved |
| Drug code(s) | LY2951742 |
| Brand name | Emgality |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG4 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | CGRP |
| Indications of clinical studies | Migraine |
| Primary therapeutic area | Neurological disorders |
| Most advanced stage of development (global) | Approved EU, US, Japan, Australia |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | July 01, 2010 |
| Start of Phase 2 | June 15, 2012 |
| Start of Phase 3 | May 15, 2015 |
| Date BLA/NDA submitted to FDA | September 27, 2017 |
| Year of first approval (global) | 2018 |
| Date of first US approval | September 28, 2018 |
| INN, US product name | Galcanezumab; galcanezumab-gnlm |
| US or EU approved indications | Preventative treatment of migraine in adults; prophylaxis of migraine in adults who have at least four migraine days per month (EU); treatment of episodic cluster headache in adults (US) |
| Company | Eli Lilly and Company |
| Licensee/Partner | Arteaus Therapeutics |
| Comments about company or candidate | Marketing authorization granted in EU in Nov 2018. Estimated PDUFA date is end of September 2018. A randomized, double-blind, placebo-controlled Phase III study of galcanezumab in patients 6 to 17 years of age with episodic migraine - the REBUILD study is expected to start in February 2018. Listed as in regulatory review in Lilly pipeline updated Oct 17, 2017. Fast track designation for cluster headache. Two Phase 3 studies started in mid-2015. Lilly bought back rights to asset in January 2014. In Arteaus pipeline as of Aug 2013. The world-wide rights to develop the antibody were licensed from Eli Lilly and Company in an innovative collaboration that leverages Lilly’s capabilities and experience developing the antibody with Arteaus’ virtual and capital-efficient approach to achieving clinical proof of concept. |
| Full address of company | Indianapolis, Indiana, United States North America United States of America https://www.lilly.com/contact-us |
S228P hinge mutation. Galcanezumab avidly binds to the human CGRP, with a binding affinity (KD) of 31 pM (4.5 ng/mL). Phe233Ala and Leu234Ala have been included into the Fc portion; No ADCC and CDC activities were detected. Each heavy chain contains N-linked glycosylation site at Asn296. The predominant form of oligosaccharides at the Asn296 site on either arm is G0F. In addition, each heavy chain contains Gln1 at the N-terminus, which can cyclize to form pyroglutamic acid. (FDA review doc).
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |