Pilopine Hs

(pilocarpine hydrochloride)

Small molecule

AAdvanz Pharma

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Clinical

Trials by Indication[1]

Dry Mouth1 trial

Pilocarpine in Treating Patients With Dry Mouth Caused by Opioids

Terminated·NNCIC Clinical Trials Group·Phase 3·NCT00003686·4 enrolled

Mucositis1 trial

Pilocarpine in Preventing Mucositis and Dry Mouth in Patients Receiving Radiation Therapy for Head and Neck Cancer

Completed· Radiation Therapy Oncology Group logo

Radiation Therapy Oncology Group·Phase 3·NCT00003139·249 enrolled

Breast Cancer1 trial

Pilocarpine in Treating Vaginal Dryness in Patients With Breast Cancer

Completed·AAlliance for Clinical Trials in Oncology·Phase 3·NCT00343382·201 enrolled

CAR1 trial

Comparison of a Compound With Pilocarpine and Brimonidine to Improve Near Vision in Healthy Presbyopic Patients

Unknown status·OOptall Vision·Phase 1·NCT05001243·11 enrolled

Sjogren's Syndrome1 trial

Oral Pilocarpine in the Treatment of the Dry Eye of Patients With Sjogrens Syndrome

Completed·FFederal University of São Paulo·Phase 3·NCT04470479·32 enrolled

Regulatory

FDA Approval Timeline[3]

Jan 1, 1982

OCUSERT PILO-40

NDA NDA017548

Jan 1, 1982

OCUSERT PILO-20

NDA NDA017431

Oct 1, 1984

PILOPINE HS

NDA NDA018796

Mar 22, 1994

SALAGEN

NDA NDA020237

Jun 22, 2010

ISOPTO CARPINE

NDA NDA200890

Oct 28, 2021

VUITY

NDA NDA214028

Oct 17, 2023

QLOSI

NDA NDA217836

Sources

References

[1]
ClinicalTrials.gov — 5 trial records for pilocarpine hydrochloride. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — pilocarpine hydrochloride compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA217836). U.S. Food & Drug Administration.
[4]
SEC EDGAR — Advanz Pharma company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: AAdvanz Pharma