Evoxac

(Cevimeline)

ApprovedSmall molecule

CCosette Pharmaceuticals, Inc.

Evoxac is one of 5 small molecule programs targeting Xerostomia. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

XerostomiaCompleted

XerostomiaApproved

Completed

Competition

Competitive Landscape

7 competitors in Xerostomia

#DrugCompanyPhaseTrials

Isopto Carpine

AAdvanz Pharma

Approved

3 2

Decadron

AAspen Global Incorporated

Approved

1 3

Ethyol

LLegacy Health System

Approved

—4

Evoxac

CCosette Pharmaceuticals, Inc.

Approved

1 5

Platinol

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Phase 1

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Xerostomia1 trial

Study of the Effectiveness of Cevimeline on Oral Health in Patients With Radiation Induced Xerostomia

Completed·AAmerican Academy of Otolaryngology-Head and Neck Surgery Foundation·Phase 4·NCT00466388·54 enrolled

Fed1 trial

Crossover Bioequivalence Study of Cevimeline 30 mg Capsules Under Fed Conditions

Completed·RRoxane Laboratories·Phase 1·NCT01903109·27 enrolled

TED1 trial

Crossover Bioequivalence Study of Cevimeline 30 mg Capsules Under Fasted Conditions

Completed·RRoxane Laboratories·Phase 1·NCT01903122·26 enrolled

Efficacy1 trial

Efficacy of Cevimeline Versus Pilocarpine in the Secretion of Saliva

Completed·UUniversity of Kentucky·N/A·NCT01690052·15 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 11, 2000

EVOXAC

NDA NDA020989

Sources

References

[1]
ClinicalTrials.gov — 4 trial records for Cevimeline. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Cevimeline compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Cevimeline. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA020989). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Cosette Pharmaceuticals, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: CCosette Pharmaceuticals, Inc.

Evoxac

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Xerostomia1 trial

Fed1 trial

TED1 trial

Efficacy1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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