Clinical Trials

Numerous clinical trials evaluate the therapeutic applications of alprostadil across Phase 1 through Phase 4 studies for cardiovascular, urological, and renal conditions, including erectile dysfunction, severe heart failure, congenital heart disease, and chronic renal disease. Sponsored by academic institutions, university hospitals, and pharmaceutical companies—such as Biopeutics Co. Ltd, Lawson Health Research Institute, and The Hospital for Sick Children—these protocols encompass varied recruitment statuses, including completed, terminated, withdrawn, and pending trials.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT00610051 NOT_YET_RECRUITING
End Stage Cardiac Failure; HFrEF - Heart Failure With Reduced Ejection Fraction; NYHF Class III-IV
Biopeutics Co., Ltd
 2026-10 PHASE3
NCT07604051 COMPLETED
Termination of Pregnancy
Dr Mudassar Saeed Pansota
 2025-11-13 PHASE4
NCT03252626 UNKNOWN
Stroke
The First Hospital of Jilin University
 2024-04-18 PHASE4
NCT06768177 ENROLLING_BY_INVITATION
Erectile Dysfunction Due to General Medical Condition; Erectile Dysfunction Following Radical Prostatectomy; Erectile Dysfunction Associated With Type 2 Diabetes Mellitus; Erectile Dysfunctions
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
 2023-04-01
NCT05475717 TERMINATED
Contrast-induced Acute Kidney Injury
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
 2022-10-20 PHASE2
NCT00610051 Not yet recruiting
Heart Failure
Biopeutics Co. Ltd
 2023-10 Phase 3
NCT04197323 UNKNOWN
Peripheral Artery Disease
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
 2019-10-01 PHASE2
NCT02895373 TERMINATED
Respiratory Distress Syndrome, Adult; Extracorporeal Membrane Oxygenation
Thomas Staudinger
 2016-07 PHASE2
NCT03892447 UNKNOWN
Children AKI Patients
Shengjing Hospital
 2019-08-01 PHASE4
NCT04312555 UNKNOWN
Critical Limb Ischemia
Assiut University
 2020-04-01 PHASE4
NCT04054115 TERMINATED
Congenital Heart Disease
The Hospital for Sick Children
 2019-07-23 PHASE1
NCT02338440 UNKNOWN
Veno-occlusive Disease; Child
Seoul National University Hospital
 2015-01 PHASE2; PHASE3
NCT03252665 UNKNOWN
ST Segment Elevation Myocardial Infarction
RenJi Hospital
 2017-09-01 PHASE4
NCT03851562 UNKNOWN
Ischemic Optic Neuropathy
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
 2018-06-13 PHASE2
NCT03682952 UNKNOWN
Chronic Renal Disease
The Affiliated Hospital of Xuzhou Medical University
 2018-02-01 PHASE4
NCT03733860 UNKNOWN
Erectile Dysfunction
Cairo University
 2018-11-01
NCT02350218 UNKNOWN
Evidence of Liver Transplantation
Asan Medical Center
 2015-03 PHASE2
NCT03669562 UNKNOWN
Lower Extremity Arterial Occlusive Diseases
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
 2018-08-07 PHASE1
NCT03489798 COMPLETED
Induction of Labor
Saint Thomas Hospital, Panama
 2018-04-05
NCT02412345 COMPLETED
Erectile Dysfunction; Renal Transplant
University of Sao Paulo
 2015-01
NCT06037525 Completed
Pain|Catheter Infection
University Hospital Augsburg
 2018-01-01 --
NCT03159559 UNKNOWN
Coronary Microvascular Perfusion in Patients With Ischemic Heart Disease
Tongji Hospital
 2017-01 PHASE4
NCT02877173 UNKNOWN
Arteriosclerosis Obliterans
Guangzhou Yipinhong Pharmaceutical CO.,LTD
 2016-08 PHASE2
NCT03296670 COMPLETED
ST Segment Elevation Myocardial Infarction; Coronary Slow Flow Phenomenon
RenJi Hospital
 2015-08-01 PHASE4
NCT02223949 UNKNOWN
Obesity; Labor Complications
Hillel Yaffe Medical Center
 2014-10 PHASE2; PHASE3
NCT02628106 COMPLETED
Diabetic Nephropathy
West China Hospital
 2015-12 PHASE4
NCT01776320 WITHDRAWN
Erectile Dysfunction
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
 2013-12 PHASE4
NCT02228850 COMPLETED
Raynaud's Phenomenon Secondary to Systemic Sclerosis
NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.)
 2014-11 PHASE2
NCT01776320 Withdrawn
Erectile Dysfunction
Lawson Health Research Institute
 2013-12 Phase 4
NCT01722513 UNKNOWN
Kidney Diseases; Diabetes Mellitus; Acute Kidney Injury; Kidney Failure, Chronic; Renal Insufficiency
Shanghai 10th People's Hospital
 2012-11 PHASE4
NCT00596752 COMPLETED
Peripheral Arterial Occlusive Disease
UCB BIOSCIENCES GmbH
 2004-03 PHASE4
NCT01810575 TERMINATED
Erectile Dysfunction
Warner Chilcott
 2013-02 PHASE2
NCT01467076 TERMINATED
Prematurity; Respiratory Insufficiency; Pulmonary Hypertension; Respiratory Distress Syndrome, Newborn
NICHD Neonatal Research Network
 2011-11 PHASE2
NCT00544076 TERMINATED
Prostate Cancer; Male Erectile Disorder; Stage I Prostate Cancer; Stage II Prostate Cancer
City of Hope Medical Center
 2006-01 PHASE3
NCT01245855 UNKNOWN
Prostaglandin E1; Percutaneous Coronary Intervention
First Affiliated Hospital, Sun Yat-Sen University
 2011-01 PHASE3
NCT01263925 COMPLETED
Stage II Peripheral Arterial Occlusive Disease; Intermittent Claudication Fontaine Stage II PAOD
UCB Pharma
 2001-04 PHASE3
NCT02889822 COMPLETED
Cardiovascular Diseases
Guangzhou Yipinhong Pharmaceutical CO.,LTD
 2010-03 PHASE1
NCT02889822 Completed
Cardiovascular Diseases
Guangzhou Yipinhong Pharmaceutical CO.LTD
 2010-03 Phase 1
NCT00619229 TERMINATED
Macular Degeneration
UCB Pharma
 2006-07 PHASE3
NCT00314548 COMPLETED
Adult Respiratory Distress Syndrome; Pulmonary Hypertension
Aga Khan University
 2006-05
NCT00507286 UNKNOWN
Erectile Dysfunction
Keogh Institute for Medical Research
 2007-05
NCT00598429 WITHDRAWN
Infant, Newborn; Respiratory Insufficiency; Pulmonary Hypertension; Respiratory Distress Syndrome, Newborn; Streptococcal Infections
NICHD Neonatal Research Network
 2008-05 PHASE2
NCT00572377 TERMINATED
Female Sexual Arousal Disorder
Cedars-Sinai Medical Center
 2007-05 PHASE1
NCT00324948 COMPLETED
Sexual Dysfunction, Physiological
VIVUS LLC
 2004-09 PHASE2
NCT00080808 COMPLETED
Prostate Cancer
M.D. Anderson Cancer Center
 2001-08 PHASE2

(data from https://clinicaltrials.gov, updated on 2025-12-15)

Check the Alprostadil (PGE1) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Alprostadil acts as a prostaglandin E1 agonist that selectively binds to G-protein-coupled EP receptors, stimulating adenylate cyclase to increase intracellular cyclic AMP levels and reduce cytosolic calcium in vascular smooth muscle cells. This biochemical cascade induces potent vasodilation and smooth muscle relaxation, providing the physiological basis for improving penile tumescence and maintaining vascular patency in clinical conditions such as erectile dysfunction and congenital heart disease.

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.