Galcanezumab
As of the edition of 20 October 2026, Galcanezumab is an antibody: marketed, first approved in 2018 (US); acts on CALCA and CALCB; US protection ends in 2030.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2021
- Kind
- Antibody
- Brand name
- Emgality
- First approved
- 27 September 2018 (US)
- Approvals on record
- 8 in 4 regions
- Holder of the most recent approval
- Eli Lilly; 2 holders in all
- Registered trials
- 36, 2 stopped early
- Disease areas
- Nervous system; Bones, joints and muscles; Ear, nose and throat; Mental health; Mouth and teeth; Pregnancy and women's health
US protection
US protection ends in 2030.
US protection ends in 2030, computed as 12 years from the first US licence because FDA publishes no date for this product. The application that gives this date is held by Eli Lilly. The date is computed, not published.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product1 listing counts towards this date. The exact date and each listing are in the product.
Companies that need a new molecule because of this drug
2 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product2 company-target rows are on route B because of Galcanezumab.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 5 | 0 | 3 | 0 |
| Phase 1 | 7 | 6 | 1 | 0 |
| Phase 2 | 5 | 4 | 0 | 1 |
| Phase 3 | 12 | 10 | 2 | 0 |
| Phase 4 | 7 | 5 | 1 | 1 |
| All trials | 36 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Eli Lilly | Applicant and Lead sponsor of trials | 2011 to now |