Methacholine
As of the edition of 20 October 2026, Methacholine is a small molecule: marketed, first approved in 1986 (US); acts on CHRM3; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2021
- Kind
- Small molecule
- Brand name
- Provocholine
- First approved
- 31 October 1986 (US)
- Approvals on record
- 5 in 3 regions
- Holder of the most recent approval
- METAPHARM (IRLANDE); 4 holders in all
- Registered trials
- 18, 2 stopped early
- Disease areas
- Immune system; Lungs and airways; Hormones; Nutrition and metabolism
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
Companies that need a new molecule because of this drug
3 companies on route B because of this drug.
Companies on route B for this drug
In the product3 companies are on route B because of Methacholine.
See the 3 companies on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| CHRM3 | Muscarinic acetylcholine receptor M3 | P20309 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 8 | 5 | 1 | 1 |
| Phase 1 | 2 | 2 | 0 | 0 |
| Phase 3 | 6 | 5 | 0 | 1 |
| Phase 4 | 2 | 2 | 0 | 0 |
| All trials | 18 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Methapharm | Acquired holder | 2003 to now |
| Santen Pharmaceutical | Later holder and Lead sponsor of trials | 2014 to now |
| Sanwa Kagaku Kenkyusho | Applicant and Lead sponsor of trials | 2014 to now |
| Roche | Originator | 1986 to 2003 |