Clinical Trials

Pilocarpine HCl has been evaluated across numerous clinical trials spanning Early Phase 1 through Phase 4 to investigate xerostomia, presbyopia, open-angle glaucoma, anisocoria, and postoperative cognitive dysfunction. Sponsored by academic medical centers and clinical research groups such as Maastricht University Medical Center and Shahid Beheshti University of Medical Sciences, these studies encompass active, completed, terminated, and withdrawn recruitment statuses. Together, these trials assess pilocarpine’s clinical utility in enhancing exocrine gland function, controlling ocular pupillary dynamics, and improving neurological outcomes.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03933631 RECRUITING
Glaucoma
Montefiore Medical Center
 2019-05-01 PHASE3
NCT07012512 NOT_YET_RECRUITING
Pupillary Constriction; Accomodation
Mansoura University
 2025-06-01
NCT06451666 UNKNOWN
Presbyopia
CSPC Ouyi Pharmaceutical Co., Ltd.
 2024-06-30 PHASE3
NCT07113210 RECRUITING
Presbyopia; Glasses; Dry Eye
Southern College of Optometry
 2025-07-18 PHASE4
NCT06783686 COMPLETED
Pupil Constriction
Novus Vision LLC
 2025-01-30 EARLY_PHASE1
NCT05506137 UNKNOWN
Xerostomia; Dry Mouth
Maastricht University Medical Center
 2023-01 PHASE3
NCT06752278 COMPLETED
Dry Eye Disease (DED)
Al-Azhar University
 2024-10-01
NCT02865473 UNKNOWN
Glaucoma
Medical University of Vienna
 2016-04-20
NCT05646719 COMPLETED
Presbyopia
Ocuphire Pharma, Inc.
 2022-12-22 PHASE3
NCT05238233 COMPLETED
Anisocoria
Prisma Health-Upstate
 2022-04-01 PHASE4
NCT05506137 Not yet recruiting
Xerostomia|Dry Mouth
Maastricht University Medical Center|ZonMw: The Netherlands Organisation for Health Research and Development
 2023-01 Phase 3
NCT05578001 UNKNOWN
Presbyopia; Pseudophakia
Isfahan University of Medical Sciences
 2022-07-01 PHASE3
NCT05564832 UNKNOWN
Near Vision
Shahid Beheshti University of Medical Sciences
 2022-08-01 EARLY_PHASE1
NCT05114486 COMPLETED
Presbyopia
Eyenovia Inc.
 2021-11-03 PHASE3
NCT05124275 COMPLETED
Presbyopia
Glaukos Corporation
 2022-01-03 PHASE2
NCT05564832 Recruiting
Near Vision
Shahid Beheshti University of Medical Sciences
 2022-08-01 Early Phase 1
NCT05119920 COMPLETED
Dry Eye Disease; Kerato Conjunctivitis Sicca
Glaukos Corporation
 2022-01-03 PHASE2
NCT05352854 UNKNOWN
Glaucoma; Myopia
Yune Zhao
 2022-05-01
NCT04732195 COMPLETED
Cystic Fibrosis
Emory University
 2022-01-20
NCT04983589 COMPLETED
Presbyopia
Allergan
 2021-09-02 PHASE3
NCT03584841 UNKNOWN
Mucoviscidosis Involving the Lung
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
 2017-03-31
NCT05006911 UNKNOWN
Presbyopia
Optall Vision
 2021-08-14 PHASE1
NCT05001243 UNKNOWN
Presbyopia
Optall Vision
 2021-08-10 PHASE1
NCT04675151 COMPLETED
Presbyopia
Ocuphire Pharma, Inc.
 2021-02-15 PHASE2
NCT04657172 COMPLETED
Presbyopia
Eyenovia Inc.
 2020-12-15 PHASE3
NCT04005079 WITHDRAWN
Open Angle Glaucoma; Ocular Hypertension
Montefiore Medical Center
 2019-06-05 PHASE3
NCT03857542 COMPLETED
Presbyopia
Allergan
 2019-03-01 PHASE3
NCT05006898 COMPLETED
Presbyopia
Optall Vision
 2020-06-01 PHASE1
NCT05006898 Completed
Presbyopia
Optall Vision
 2020-06-01 Phase 1
NCT02613013 UNKNOWN
Glaucoma, Angle-Closure
Sun Yat-sen University
 2015-10
NCT04195100 COMPLETED
Patients of Advanced Age (≥ 70 Years) With a Clinical Diagnosis of Chronic Dry Mouth
Maastricht University Medical Center
 2019-04-01 EARLY_PHASE1
NCT03804268 COMPLETED
Presbyopia
Allergan
 2018-12-21 PHASE3
NCT03460964 TERMINATED
Diabetes Mellitus
University of California, San Diego
 2018-05-01
NCT03825081 UNKNOWN
Presbyopia; Pseudophakia
Massachusetts Eye and Ear Infirmary
 2019-01-21 EARLY_PHASE1
NCT04005079 Withdrawn
Open Angle Glaucoma|Ocular Hypertension
Montefiore Medical Center
 2019-06-05 Phase 3
NCT03912792 Withdrawn
XLHED
Dermelix Biotherapeutics LLC.
 2019-06-28 --
NCT02754570 COMPLETED
Glaucoma, Open-angle; Hypertension, Ocular
University of Colorado, Denver
 2016-07
NCT02935894 COMPLETED
Stability & Variability of Lipid-derived Molecules in Sweat
USDA, Western Human Nutrition Research Center
 2016-11-28
NCT02982577 UNKNOWN
Xerostomia
University of Sao Paulo
 2016-04 PHASE4
NCT02310789 COMPLETED
Cystic Fibrosis
Richard Barry Moss
 2015-07-31
NCT02420782 COMPLETED
Healthy Volunteers
Astellas Pharma Europe B.V.
 2015-05 PHASE1
NCT02447315 COMPLETED
Healthy Subjects
Astellas Pharma Europe B.V.
 2015-05 PHASE1
NCT00656513 COMPLETED
Head and Neck Cancer; Xerostomia
Radiation Therapy Oncology Group
 2008-09 PHASE2; PHASE3
NCT01627626 COMPLETED
Xerostomia
Jeong-seong Kwon
 2011-08
NCT01690052 COMPLETED
Dry Mouth
University of Kentucky
 2009-01
NCT01036035 COMPLETED
Incontinence
TheraVida, Inc.
 2009-09 PHASE1
NCT00343382 COMPLETED
Breast Cancer; Vaginal Dryness
Alliance for Clinical Trials in Oncology
 2006-12 PHASE3
NCT00438048 COMPLETED
Primary Sjogren; Secondary Sjogren; Xerostomia
Pontificia Universidad Catolica de Chile
 2006-11 PHASE4
NCT00762645 COMPLETED
Angle-closure Glaucoma
Alcon Research
 2007-02 PHASE4
NCT00624039 UNKNOWN
Presbyopia; Cataract
Samsung Medical Center
 2006-05
NCT00003686 TERMINATED
Oral Complications; Quality of Life
NCIC Clinical Trials Group
 1998-05-22 PHASE3
NCT00804115 UNKNOWN
Exfoliation Syndrome; Glaucoma; Ocular Hypertension
The New York Eye & Ear Infirmary
 2000-08
NCT04470479 COMPLETED
Dry Eye
Federal University of São Paulo
 2005-03-01 PHASE3
NCT00602524 COMPLETED
Dry Mouth
Roxane Laboratories
 2004-08
NCT00618059 COMPLETED
Dry Mouth
Roxane Laboratories
 2004-08
NCT00601874 COMPLETED
Dry Mouth
Roxane Laboratories
 2003-09
NCT00601211 COMPLETED
Dry Mouth
Roxane Laboratories
 2003-09
NCT00003139 COMPLETED
Head and Neck Cancer; Oral Complications
Radiation Therapy Oncology Group
 1998-03 PHASE3
NCT00803803 COMPLETED
Open-angle Glaucoma
Wills Eye
 1978-08 PHASE4
NCT00168181 COMPLETED
Cancer; Head and Neck Cancer
Alberta Health services
 2002-04 PHASE3

(data from https://clinicaltrials.gov, updated on 2025-11-10)

Check the Pilocarpine HCl product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Pilocarpine HCl acts as a muscarinic acetylcholine receptor agonist that directly binds to muscarinic receptors to stimulate parasympathetic signaling pathways and intracellular calcium mobilization. This cholinergic activation drives smooth muscle contraction and exocrine gland secretion, inducing physiological responses such as pupillary miosis and increased salivation that underlie its clinical application in managing xerostomia, presbyopia, and open-angle glaucoma.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.