Evoxac

(Cevimeline)

ApprovedSmall molecule

CCosette Pharmaceuticals, Inc.

Evoxac is one of 17 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

XerostomiaActive, not recruiting

XerostomiaApproved

Active, not recruiting

Competition

Competitive Landscape

38 competitors in Xerostomia

#DrugCompanyPhaseTrials

Isopto Carpine

AAdvanz Pharma

Approved

3 2

Ethyol

LLegacy Health System

Approved

—3

Decadron

AAspen Global Incorporated

Approved

—4

Evoxac

CCosette Pharmaceuticals, Inc.

Approved

1 5

Biotene

UUniversity of Southern California

Approved

1 6

Aloevera

GGovernment Dental College and Research Institute, Bangalore

Phase 3

1 7

Stem Cells

KKang Stem Biotech Co., Ltd.

Phase 2

1 8

Amifostine Trihydrate

GGynecologic Oncology Group

Phase 2

1 9

Mesenchymal Stem Cell

RRohto Pharmaceutical Co., Ltd.

Phase 2

1 10

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]

TED1 trial

Crossover Bioequivalence Study of Cevimeline 30 mg Capsules Under Fasted Conditions

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

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

Efficacy1 trial

Efficacy of Cevimeline Versus Pilocarpine in the Secretion of Saliva

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

Fed1 trial

Crossover Bioequivalence Study of Cevimeline 30 mg Capsules Under Fed Conditions

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

TED1 trial

Xerostomia1 trial

Efficacy1 trial

Fed1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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