Drugs / Cevimeline
Cevimeline
also known as
AF-102B · Cevimelina · Cevimeline hcl · CEVIMELINE HYDROCHLORIDE · Cevimeline hydrochloride hemihydrate · Cevimeline hydrochloride hydrate · Evoxac · FKS-508 · +4 more
Small molecule targets CHRM1, CHRM3 via activation
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | EVOXAC | — | 2000-01-11 | fda.gov ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT06543303 | Dec 2024 → Jan 2026 | dry eye syndrome | BioTheraVision, Inc. | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT00017511 | Jun 2001 → Mar 2003 | head and neck cancer, mouth disorder, radiation-induced disorder | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT00466388 | May 2007 → Jun 2009 | — | American Academy of Otolaryngology-Head and Neck Surgery Foundation | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| — | NCT01690052 Comparator | Jan 2009 → Jun 2010 | — | University of Kentucky | Completed | No outcome recorded |
Press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-03-13 | Zydus Lifesciences Limited | Zydus receives final approval from USFDA for Cevimeline Hydrochloride Capsules 30mg zyduslife.com ↗ |
| 2017-01-02 | Lupin Limited | Lupin Receives FDA Approval for Generic Evoxac® Capsules lupin.com ↗ |
Evidence & citations 18 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Cevimeline | “Efficacy of Cevimeline Versus Pilocarpine in the Secretion of Saliva” NCT01690052 ↗ |
| Known as | AF-102B | ChEMBL registry synonym — accepted as the source's own label CHEMBL168815 ↗ |
| Known as | Cevimelina | ChEMBL registry synonym — accepted as the source's own label CHEMBL168815 ↗ |
| Known as | Cevimeline hcl | ChEMBL registry synonym — accepted as the source's own label CHEMBL168815 ↗ |
| Known as | CEVIMELINE HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL168815 ↗ |
| Known as | Cevimeline hydrochloride hemihydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL168815 ↗ |
| Known as | Cevimeline hydrochloride hydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL168815 ↗ |
| Known as | Evoxac | ChEMBL registry synonym — accepted as the source's own label CHEMBL168815 ↗ |
| Known as | FKS-508 | ChEMBL registry synonym — accepted as the source's own label CHEMBL168815 ↗ |
| Known as | Saligren | ChEMBL registry synonym — accepted as the source's own label CHEMBL168815 ↗ |
| Known as | SND-5008 | ChEMBL registry synonym — accepted as the source's own label CHEMBL168815 ↗ |
| Known as | SNI-2011 | ChEMBL registry synonym — accepted as the source's own label CHEMBL168815 ↗ |
| Known as | SNK-508 | ChEMBL registry synonym — accepted as the source's own label CHEMBL168815 ↗ |
| Action | Activate | “Muscarinic acetylcholine receptor M3 agonist” CHEMBL168815 ↗1“Muscarinic acetylcholine receptor M1 agonist” CHEMBL168815 ↗ |
| Modality | Small molecule | — CHEMBL168815 ↗ |
| Route | Oral | “Patients receive oral cevimeline 3 times daily” NCT00017511 ↗ |
| Target | CHRM1 | “Muscarinic acetylcholine receptor M1 agonist” CHEMBL168815 ↗ |
| Target | CHRM3 | “Muscarinic acetylcholine receptor M3 agonist” CHEMBL168815 ↗ |