Glycopyrronium
As of the edition of 20 October 2026, Glycopyrronium is a small molecule: marketed, first approved in 1982 (US); acts on CHRM1, CHRM2 and CHRM3 and 2 more; no US protection of its own is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2025
- Kind
- Small molecule
- Brand name
- Robinul
- First approved
- 1 January 1982 (US)
- Approvals on record
- 49 in 6 regions
- Holder of the most recent approval
- Chiesi Farmaceutici; 18 holders in all
- Withdrawn from market
- 30 August 2026 (in some regions)
- Registered trials
- 140, 11 stopped early
- Disease areas
- Lungs and airways; Immune system; Skin and connective tissue; Nervous system; Digestive system; Heart and blood vessels
US protection
No US protection of its own is listed.
The FDA registers list no drug-substance patent or exclusivity of its own that counts for this drug.
Coronado Biosciences holds a later exclusivity on its own new formulation or combination product, ending 2033; it does not protect the original drug.
This is the US only.
Companies that need a new molecule because of this drug
10 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product10 company-target rows are on route B because of Glycopyrronium.
See the 10 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 24 | 15 | 5 | 1 |
| Phase 1 | 16 | 14 | 0 | 1 |
| Phase 2 | 33 | 28 | 3 | 1 |
| Phase 3 | 40 | 33 | 1 | 5 |
| Phase 4 | 27 | 19 | 2 | 3 |
| All trials | 140 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Acquired holder | 2003 to now |
| Shionogi | Later holder and Lead sponsor of trials | 2007 to now |
| Novartis | Applicant and Lead sponsor of trials | 2007 to now |
| Sumitomo Pharma | Acquired holder, Later holder and Lead sponsor of trials | 2009 to now |
| Chiesi Farmaceutici | Later holder and Lead sponsor of trials | 2010 to now |
| Merz Pharma GmbH & Co. KGaA | Acquired holder | 2012 to now |
| Coronado Biosciences | Acquired holder and Lead sponsor of trials | 2013 to now |
| Casper Pharma | Acquired holder | 2016 to now |
| Proveca Pharma | Later holder | 2016 to now |
| AstraZeneca | Applicant and Lead sponsor of trials | 2017 to now |
| Dermira | Later holder | 2018 to now |
| Exela Pharma Sciences | Later holder | 2018 to now |
| Edenbridge Pharmaceuticals | Later holder | 2021 to now |
| Hikma Pharmaceuticals | Acquired holder | 2021 to now |
| Maruho | Later holder | 2022 to now |
| Fresenius Kabi | Later holder | 2022 to now |