What development phase is CEVIMELINE HYDROCHLORIDE in?

CEVIMELINE HYDROCHLORIDE is FDA-approved (marketed).

Last reviewed 2026-04-20 · How we verify

CEVIMELINE HYDROCHLORIDE

FDA-approved approved Small molecule Quality 0/100

At a glance

Generic name	CEVIMELINE HYDROCHLORIDE
Modality	Small molecule
Phase	FDA-approved
First approval	2000

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Cevimeline in Treating Patients With Dry Mouth Caused by Radiation Therapy for Head and Neck Cancer (PHASE3)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
FDA label	Mechanism, indications, dosing, boxed warnings, drug interactions
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

CEVIMELINE HYDROCHLORIDE CI brief — competitive landscape report
CEVIMELINE HYDROCHLORIDE updates RSS · CI watch RSS