cevimeline hydrochloride
Trade name: evoxac
Approved
Jan 11, 2000
Cevimeline is a cholinergic agonist, which binds to muscarinic receptors. Muscarinic agonists in sufficient dosage can increase secretion of exocrine glands, such as salivary and sweat glands and increase tone of the smooth muscle in the gastrointestinal and urinary tracts. Cevimeline is indicated for the treatment of symptoms of dry mouth in patients with Sjögren’s Syndrome. Known side effects include nausea, vomiting, diarrhea, excessive sweating, rash, headache, runny nose, cough, drowsiness, hot flashes, blurred vision, and difficulty sleeping. Cevimeline should be administered with caution to patients taking beta adrenergic antagonists, because of the possibility of conduction disturbances. Drugs with para-sympathomimetic effects administered concurrently with cevimeline can be expected to have additive effects. Cevimeline might interfere with desirable antimuscarinic effects of drugs used concomitantly. — NCATS
Clinical trial activity
6 trials · 8 clinical orgs · 13 marketing orgs
Earliest trial started Jun 1, 2001 (NCT00017511)
Timeline
2000s
- Jan 11, 2000
Snow Brand — Earliest FDA Approval
- Jan 11, 2000
Cosette — Marketing Organization
- Jan 11, 2000
Snow Brand — NDA Organization
- Jan 11, 2000
Daiichi Sankyo — NDA Secondary Org
- Jan 11, 2000
Cosette — NDA Secondary Org
- Jan 1, 2001
Daiichi Sankyo — Earliest Phase 3 Sponsor(trial)
- Jan 1, 2009
Earliest Phase 1 Sponsor(trial)
2010s
- Aug 25, 2011
Apotex — Marketing Organization
- Jul 8, 2013
West-Ward Pharmaceutical — Marketing Organization
- Jul 8, 2013
Hikma — Marketing Organization
- Jun 4, 2014
Rising Pharmaceuticals — Marketing Organization
- Dec 30, 2016
Novel Anti-Infective Technologies, LLC — Marketing Organization
2020s
- Apr 6, 2023
Rubicon Research — Marketing Organization
- Apr 18, 2023
Aurobindo Pharma — Marketing Organization
- Nov 8, 2023
Bionpharma Inc — Marketing Organization
- Jan 1, 2024
Earliest Phase 2 Sponsor(trial)
- Sep 20, 2024
Macleods Pharmaceuticals, Ltd — Marketing Organization
- Mar 11, 2026
Zydus Discovery DMCC — Marketing Organization
Indications
Approved for
Mechanism of action
CHRM1 agonist
Role in regulating gastric secretion, M1 likely involved
CHRM3 agonist
Role in regulating gastric secretion, M3 likely involved
Approval history
- approvedJan 11, 2000
Chemistry & pharmacology
SMILES
CC1OC2(CS1)CN1CCC2CC1- Mol. weight
- 199.32 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- Yes
- Chirality
- Racemic Mixture
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL168815 ↗
- WikipediaCevimeline ↗
- NCATSK9V0CDQ56E ↗
- ChEMBLCHEMBL2218917 ↗
Also known as
- 2-methyspiro(1,3-oxathiolane-5,3)quinuclidine
- 2-methyspiro(1,3-oxathiolane-5,3)quinuclidine
- 2-methyspiro(1,3-oxathiolane-5,3)quinuclidine
- af102b
- af102b
- af102b
- af 102b
- af-102b
- af 102b, (cis-(+))-isomer
- af 102b, (trans)-isomer
- cevimelina
- cevimelina
- cevimeline
- cevimeline
- cevimeline
- cevimeline
- cevimeline
- cevimeline
- cevimeline
- cevimeline
- cevimeline hcl
- cevimeline hcl
- cevimeline hcl
- cevimeline hydrochloride
- cevimeline hydrochloride
- cevimeline hydrochloride
- cevimeline hydrochloride
- cevimeline hydrochloride
- cevimeline hydrochloride
- cevimeline hydrochloride hemihydrate
- cevimeline hydrochloride hydrate
- cevimeline hydrochloride hydrate
- cevimeline hydrochloride hydrate
- cevimeline hydrochloride hydrate
- cevimeline hydrochloride hydrate
- cevimelinum
- cevimelinum
- evoxac
- evoxac
- evoxac
- evoxac
- evoxac
- fks 508
- fks-508
- fks-508
- fks-508
- snd-5008
- snd-5008
- sni 2011
- sni 2011
- sni 2011
- sni-2011
- sni-2011
- sni-2011
- snk-508
- snk-508
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06543303 | Phase 2 | Nov 15, 2024 | Biothera |
| NCT01903109 | Early Phase 1 (Phase 1) | Feb 1, 2009 | Novum Pharmaceutical Research Services, Roxane Laboratories |
| NCT01903122 | Early Phase 1 (Phase 1) | Feb 1, 2009 | Novum Pharmaceutical Research Services, Roxane Laboratories |
| NCT01690052 | N/A | Jan 1, 2009 | Indiana University, University of Kentucky |
| NCT00466388 | Phase 4 | May 1, 2007 | American Academy of Otolaryngology-Head and Neck Surgery Foundation, Duke University |
| NCT00017511 | Phase 3 | Jun 1, 2001 | Daiichi Sankyo |
Organizations
Research & Development (8)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Novum Pharmaceutical Research Services | For profit | 2 | 0 | 1 | 2009 |
| Roxane Laboratories | For profit | 2 | 2 | 1 | 2009 |
| American Academy of Otolaryngology-Head and Neck Surgery Foundation | Academic/Hospital | 1 | 1 | 1 | 2007 |
| Biothera | For profit | 1 | 1 | 1 | 2024 |
| Daiichi Sankyo | For profit | 1 | 1 | 1 | 2001 |
| Duke University | Academic/Hospital | 1 | 0 | 1 | 2007 |
| Indiana University | Academic/Hospital | 1 | 0 | 1 | 2009 |
| University of Kentucky | Academic/Hospital | 1 | 1 | 1 | 2009 |
Marketing (17)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Apotex | For profit | MKTG | Aug 25, 2011 |
| Aurobindo Pharma | For profit | MKTG | Apr 18, 2023 |
| Bionpharma Inc | For profit | MKTG | Nov 8, 2023 |
| Cosette | For profit | MKTG | Jan 11, 2000 |
| Cosette | For profit | NDA2 | Jan 11, 2000 |
| Daiichi Sankyo | For profit | NDA2 | Jan 11, 2000 |
| Hikma | For profit | MKTG | Jul 8, 2013 |
| Hikma | For profit | SYN | Jul 8, 2013 |
| Macleods Pharmaceuticals, Ltd | For profit | MKTG | Sep 20, 2024 |
| Novel Anti-Infective Technologies, LLC | For profit | MKTG | Dec 30, 2016 |
| Rising Pharmaceuticals | For profit | MKTG | Jun 4, 2014 |
| Rising Pharmaceuticals | For profit | SYN | Jun 4, 2014 |
| Rubicon Research | For profit | MKTG | Apr 6, 2023 |
| Rubicon Research | For profit | SYN | Apr 6, 2023 |
| Snow Brand | For profit | NDA | Jan 11, 2000 |
| West-Ward Pharmaceutical | For profit | MKTG | Jul 8, 2013 |
| Zydus Discovery DMCC | For profit | MKTG | Mar 11, 2026 |