Tadalafil has been evaluated in numerous clinical trials spanning Early Phase I through Phase IV. Sponsored prominently by academic institutions such as the University of Florida and the University of Arizona, these investigations target urological conditions like erectile dysfunction, overactive bladder, and benign prostatic hyperplasia, as well as non-urological disorders including Duchenne muscular dystrophy, ischemic stroke, cerebral small vessel disease, and gastric adenocarcinoma. Active Phase II trials evaluate tadalafil for cerebral hemodynamics and as an adjuvant therapy in gastroesophageal cancers, complementing a broader landscape of completed and upcoming studies.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT05937854 | RECRUITING | Chronic Obstructive Pulmonary Disease; Pulmonary Hypertension; Dyspnea |
VA Office of Research and Development |
2024-04-01 | PHASE2 |
| NCT07245680 | RECRUITING | Pulmonary Arterial Hypertension (PAH); Comorbidities; Cardiovascular Disease (CVD) |
Assistance Publique - Hôpitaux de Paris |
2026-04-28 | PHASE3 |
| NCT07537855 | NOT_YET_RECRUITING | Erectile Dysfunction |
Northwestern University |
2026-09 | PHASE2 |
| NCT07172815 | NOT_YET_RECRUITING | Alzheimer Disease |
Imperial College London |
2025-09 | PHASE2 |
| NCT06968962 | RECRUITING | Pulmonary Arterial Hypertension (PAH) |
Second Affiliated Hospital, Zhejiang University, School of Medicine |
2025-05-14 | |
| NCT07466030 | NOT_YET_RECRUITING | BPH (Benign Prostatic Hyperplasia) |
Assiut University |
2026-03-01 | PHASE1 |
| NCT07576335 | NOT_YET_RECRUITING | Erectile Dysfunction Following Radical Prostatectomy; Prostate Cancer; Urinary Incontinence Following Surgical Procedure |
Surgical Outcomes Research Centre (SOuRCe) |
2026-05-01 | PHASE2 |
| NCT07654413 | RECRUITING | Acute Urinary Retention; Benign Prostatic Hyperplasia; Benign Prostatic Obstruction |
Beni-Suef University |
2026-06-08 | PHASE4 |
| NCT05844462 | RECRUITING | Pulmonary Hypertension; Chronic Obstructive Pulmonary Disease |
Assistance Publique - Hôpitaux de Paris |
2024-02-01 | PHASE3 |
| NCT07636161 | NOT_YET_RECRUITING | Type 2 Diabetes; Type 2 Diabetes (T2DM) |
University of Miami |
2026-09 | PHASE4 |
| NCT07753720 | RECRUITING | Erectile Dysfunction; Tadalafil |
Al-Azhar University |
2026-08-13 | PHASE4 |
| NCT06717711 | RECRUITING | Prostate Carcinoma; Erectile Function; Genito Urinary Cancer |
Regina Elena Cancer Institute |
2023-09-15 | PHASE3 |
| NCT05179876 | RECRUITING | Hypertension, Pulmonary |
Actelion |
2022-05-04 | PHASE3 |
| NCT07722884 | RECRUITING | Safety; Efficacy; Tamsulosin; Monotherapy; Tadalafil; Lower Urinary Tract Symptoms; Benign Prostatic Hyperplasia |
Ain Shams University |
2026-07-01 | |
| NCT05051436 | RECRUITING | Pre-diabetes; Obesity |
Philip Kern |
2021-12-13 | PHASE4 |
| NCT07391579 | RECRUITING | Erectile Dysfunctions |
Mansoura University |
2025-12-01 | PHASE4 |
| NCT06290713 | RECRUITING | Duchenne Muscular Dystrophy; Duchenne Disease; Muscular Dystrophy; Muscular Dystrophy in Children; Vasodilation; Exercise; DMD |
University of Florida |
2024-06-05 | PHASE2 |
| NCT07642505 | RECRUITING | Erectile Dysfunction |
Beni-Suef University |
2026-06-08 | PHASE4 |
| NCT05206955 | RECRUITING | Fontan Palliation |
Mayo Clinic |
2022-09-16 | PHASE3 |
| NCT07177326 | NOT_YET_RECRUITING | Erectile Dysfunction |
Assiut University |
2025-10-01 | PHASE3 |
| NCT07416968 | RECRUITING | Overactive Bladder (OAB); Overactive Bladder Syndrome |
Mansoura University |
2025-09-01 | PHASE4 |
| NCT07562282 | RECRUITING | Kidney Stone; Ureteric Stone |
Ain Shams University |
2025-12-01 | |
| NCT05709574 | ACTIVE_NOT_RECRUITING | Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma |
University of Arizona |
2023-04-20 | PHASE2 |
| NCT05052879 | UNKNOWN | Erectile Dysfunction; Premature Ejaculation |
EMS |
2024-07 | PHASE3 |
| NCT07499804 | RECRUITING | IVF; Infertility, Female |
Beni-Suef University |
2023-10-01 | PHASE4 |
| NCT07563647 | COMPLETED | Erectile Dysfunction; Left Ventricular Diastolic Dysfunction; Metabolic Syndrome |
Kafrelsheikh University |
2025-05-05 | PHASE4 |
| NCT06805513 | COMPLETED | Erectile Dysfunction |
Sanofi |
2025-01-30 | PHASE3 |
| NCT07117383 | NOT_YET_RECRUITING | Erectile Dysfunction |
Aspargo Labs, Inc |
2026-01 | PHASE1 |
| NCT07715448 | COMPLETED | Benign Prostatic Hyperplasia; Lower Urinary Tract Symptoms; Erectile Dysfunction |
Beni-Suef University |
PHASE4 | |
| NCT07574268 | COMPLETED | Erectile Dysfunction |
Menoufia University |
2025-05-01 | PHASE4 |
| NCT07602608 | COMPLETED | Erectile Dysfunction |
Benha University |
2025-04-15 | PHASE4 |
| NCT07690566 | COMPLETED | Diabetic Foot; Wound Healing Delayed; Diabete Mellitus; Amputation |
Deraya University |
2025-09-01 | |
| NCT07312955 | COMPLETED | Overactive Bladder |
Ain Shams University |
2025-05-15 | |
| NCT06350773 | COMPLETED | Group 2 Pulmonary Hypertension; CpcPH |
Beni-Suef University |
2023-03-10 | |
| NCT06442020 | RECRUITING | Erectile Dysfunction |
Regina Elena Cancer Institute |
2023-09-15 | |
| NCT05195775 | ACTIVE_NOT_RECRUITING | Duchenne Muscular Dystrophy |
University of Florida |
2021-12-14 | PHASE2; PHASE3 |
| NCT06583590 | RECRUITING | Erectile Dysfunction With Diabetes Mellitus |
Aswan University Hospital |
2024-08-01 | PHASE2; PHASE3 |
| NCT04762082 | UNKNOWN | Erectile Dysfunction |
Seattle Gummy Company |
2025-05-01 | PHASE1 |
| NCT06962462 | NOT_YET_RECRUITING | Erectile Dysfunction Associated With Type 2 Diabetes Mellitus |
South Valley University |
2025-05-05 | |
| NCT06491108 | UNKNOWN | Enlarged Prostate With Lower Urinary Tract Symptoms |
Tanta University |
2024-06-01 | PHASE3 |
| NCT05955001 | RECRUITING | Erectile Dysfunction; Lower Urinary Tract Symptoms |
Mansoura University |
2023-04-01 | PHASE2; PHASE3 |
| NCT04684589 | COMPLETED | Obesity |
Vanderbilt University Medical Center |
2021-03-16 | PHASE2 |
| NCT06543628 | COMPLETED | Erectile Dysfunction |
Second Affiliated Hospital, Zhejiang University, School of Medicine |
2024-08-11 | |
| NCT06947265 | COMPLETED | Erectile Dysfunctions |
Fayoum University Hospital |
2024-01-14 | PHASE4 |
| NCT05030623 | WITHDRAWN | Major Depressive Disorder |
Sadat City University |
2021-08-01 | PHASE1; PHASE2 |
| NCT05558007 | RECRUITING | Erectile Dysfunction Following Radical Prostatectomy; Erectile Dysfunction; Prostate Cancer; Radical Prostatectomy |
Biozeus Biopharmaceutical S.A. |
2023-11-22 | PHASE2 |
| NCT06520839 | UNKNOWN | Erectile Dysfunction With Diabetes Mellitus |
University Medical Centre Ljubljana |
2024-05-17 | PHASE3 |
| NCT05173896 | ACTIVE_NOT_RECRUITING | Cerebral Small Vessel Diseases; Stroke, Ischemic |
Christina Kruuse |
2022-05-31 | PHASE2 |
| NCT07761806 | COMPLETED | Erectile Dysfunction |
Ain Shams University |
2024-01-15 | PHASE2; PHASE3 |
| NCT06466369 | COMPLETED | BPH With Other Lower Urinary Tract Symptoms |
Al-Azhar University |
2024-03-15 | PHASE3 |
| NCT06553937 | COMPLETED | PAH |
Humanis Saglık Anonim Sirketi |
2024-05-10 | PHASE1 |
| NCT06553924 | COMPLETED | PAH |
Humanis Saglık Anonim Sirketi |
2024-05-14 | PHASE1 |
| NCT06809205 | COMPLETED | BPH With Other Lower Urinary Tract Symptoms |
Fayoum University Hospital |
2023-04-20 | PHASE4 |
| NCT06707181 | COMPLETED | Lower Ureteral Stones |
Beni-Suef University |
2023-11-01 | PHASE3 |
| NCT06213077 | UNKNOWN | Erectile Dysfunction |
RHA Investments Ltd |
2023-12-12 | |
| NCT05014776 | COMPLETED | Pancreatic Cancer |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
2022-08-22 | PHASE2 |
| NCT06290713 | Not yet recruiting | Duchenne Muscular Dystrophy|Duchenne Disease|Muscular Dystrophy|Muscular Dystrophy in Children|Vasodilation|Exercise|DMD |
University of Florida|National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
2024-03 | Phase 2 |
| NCT07333976 | COMPLETED | Prostate Cancer Metastatic Disease; Chemotherapy Induced Peripheral Neuropathy (CIPN); Neurotoxicity |
Tri-Service General Hospital (TSGH) |
2020-01-05 | PHASE2 |
| NCT05884957 | COMPLETED | Erectile Dysfunction; Diabetes Mellitus |
Egymedicalpedia |
2023-06-01 | |
| NCT05823506 | UNKNOWN | Erectile Dysfunction |
Saint Petersburg State University, Russia |
2023-02-01 | |
| NCT05971667 | UNKNOWN | IVF |
Beni-Suef University |
2023-07-30 | PHASE2; PHASE3 |
| NCT05537272 | UNKNOWN | Lower Urinary Tract Symptoms; Voiding Disorders; Pain; Quality of Life |
University Hospital of Split |
2022-09-01 | PHASE4 |
| NCT05142254 | COMPLETED | Priapism Due to Sickle Cell Disease |
Vanderbilt University Medical Center |
2022-04-01 | PHASE2 |
| NCT05466695 | UNKNOWN | Erectile Dysfunction and Neutrophil Lymphocyte Ratio |
Assiut University |
2022-08-01 | EARLY_PHASE1 |
| NCT04947631 | COMPLETED | Benign Prostatic Hyperplasia |
Dongkook Pharmaceutical Co., Ltd. |
2021-07-27 | PHASE3 |
| NCT04757662 | COMPLETED | Grade III Astrocytoma; Grade IV Astrocytoma; Astrocytoma, Grade IV; Astrocytoma, Grade III |
Washington University School of Medicine |
2021-05-14 | PHASE1 |
| NCT05884957 | Completed | Erectile Dysfunction|Diabetes Mellitus |
Egymedicalpedia |
2023-06-01 | Not Applicable |
| NCT05709574 | Recruiting | Gastric Adenocarcinoma|Gastroesophageal Junction Adenocarcinoma |
University of Arizona |
2023-04-20 | Phase 2 |
| NCT05487755 | COMPLETED | Diabetic Nephropathy Type 2 |
Tanta University |
2022-02-01 | PHASE3 |
| NCT03177746 | UNKNOWN | Premature Ejaculation; Erectile Dysfunction; Safety Issues |
Neutec Ar-Ge San ve Tic A.Ş |
2022-12-31 | PHASE4 |
| NCT07447518 | COMPLETED | Lower Urinary Tract Symptoms |
Kafrelsheikh University |
2022-09-22 | EARLY_PHASE1 |
| NCT07206706 | COMPLETED | Management of Ureteric Stent Related LUTS and Pain |
Ain Shams University |
2022-05-01 | PHASE1; PHASE2 |
| NCT06184334 | COMPLETED | Overactive Bladder |
Elsayed Abdelhalim Elsayed |
2022-09-14 | |
| NCT05146674 | UNKNOWN | Lower Urinary Tract Symptoms |
Mansoura University |
2022-01-01 | |
| NCT03785210 | TERMINATED | Hepatocellular Carcinoma; Hepatocellular Cancer; Metastatic Pancreatic Cancer; Metastatic Colorectal Cancer; Liver Metastasis |
National Cancer Institute (NCI) |
2019-06-05 | PHASE2 |
| NCT02998736 | COMPLETED | Abdominal Cancer |
Ottawa Hospital Research Institute |
2017-11-21 | PHASE1 |
| NCT03642366 | UNKNOWN | Erectile Dysfunction |
Institute for the Study of Urological Diseases, Greece |
2018-08-27 | |
| NCT05789732 | COMPLETED | Lower Ureteric Stones; Medical Expulsive Therapy; Tadalafil; Silodosin |
Benha University |
2022-03-30 | |
| NCT03904693 | COMPLETED | Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH) |
Actelion |
2019-07-29 | PHASE3 |
| NCT05466695 | Not yet recruiting | Erectile Dysfunction and Neutrophil Lymphocyte Ratio |
Assiut University |
2022-08-01 | Early Phase 1 |
| NCT05494567 | UNKNOWN | Benign Prostatic Hyperplasia; Overactive Bladder |
Mansoura University |
2021-11-08 | PHASE4 |
| NCT04984993 | COMPLETED | Erectile Dysfunction |
Futura Medical Developments Ltd. |
2021-09-14 | PHASE3 |
| NCT04500860 | COMPLETED | Female Patients With Overactive Bladder Syndrome or Female Patients With Urgency or Urgency Urinary Incontinence |
Kasr El Aini Hospital |
2020-12-01 | PHASE1 |
| NCT04483115 | COMPLETED | Pulmonary Arterial Hypertension |
Vigonvita Life Sciences |
2020-11-16 | PHASE2 |
| NCT05236231 | COMPLETED | Healthy |
Actelion |
2022-02-04 | PHASE1 |
| NCT05266651 | UNKNOWN | Sexual Dysfunction |
Kasr El Aini Hospital |
2022-03-10 | PHASE2; PHASE3 |
| NCT05173896 | Recruiting | Cerebral Small Vessel Diseases|Stroke Ischemic |
Christina Kruuse|Danish Research Centre for Magnetic Resonance|Bispebjerg Hospital|Rigshospitalet Denmark|Hillerod Hospital Denmark|University of Copenhagen|The Novo Nordic Foundation|Herlev Hospital |
2022-05-31 | Phase 2 |
| NCT03993353 | COMPLETED | Head and Neck Cancer; Head and Neck Squamous Cell Carcinoma; Head and Neck Carcinoma; Head and Neck Cancer Stage III; Head and Neck Cancer Stage IV; Head and Neck Cancer Metastatic; Cancer; Cancer of Esophagus; Cancer, Metastatic; Cancer of Head and Neck; Cancer of Mouth; Cancer of Neck |
University of California, San Diego |
2020-04-07 | PHASE2 |
| NCT03229889 | COMPLETED | Nephrolithiasis |
University of California, Irvine |
2017-06-07 | PHASE4 |
| NCT04641507 | UNKNOWN | Lower Ureteric Stones |
Beni-Suef University |
2020-01-01 | PHASE4 |
| NCT05199727 | UNKNOWN | Erectile Dysfunction |
Menoufia University |
2021-09-01 | |
| NCT05095077 | COMPLETED | Urinary Incontinence,Stress; Fecal Incontinence |
University Hospital Bispebjerg and Frederiksberg |
2021-08-01 | PHASE1 |
| NCT02999906 | WITHDRAWN | Pulmonary Arterial Hypertension |
United Therapeutics |
2017-10 | PHASE3 |
| NCT05109377 | UNKNOWN | Erectile Dysfunction |
Ankara Training and Research Hospital |
2021-06-24 | |
| NCT03049540 | COMPLETED | Heart Defects, Congenital; Transposition of Great Vessels With Ventricular Inversion |
Insel Gruppe AG, University Hospital Bern |
2017-10-25 | PHASE3 |
| NCT04069936 | TERMINATED | Non Small Cell Lung Cancer; Lung Cancer; Lung Cancer Metastatic; Lung Cancer, Non-small Cell; Non Small Cell Lung Cancer Metastatic; NSCLC; Non-small Cell Lung Cancer; Non-small Cell Lung Cancer Metastatic |
WindMIL Therapeutics |
2019-10-15 | PHASE2 |
| NCT05818670 | COMPLETED | BPH |
Mansoura University |
2020-11-11 | PHASE4 |
| NCT04540744 | COMPLETED | Healthy |
Janssen Research & Development, LLC |
2021-04-30 | PHASE1 |
| NCT04433559 | UNKNOWN | Sexual Dysfunctions, Psychological |
Lidia Larrañaga |
2020-08 | PHASE3 |
| NCT04211272 | COMPLETED | Healthy |
Actelion |
2020-01-14 | PHASE1 |
| NCT05446493 | COMPLETED | Erectile Dysfunction; Erectile Dysfunction With Diabetes Mellitus |
Aswan University |
2019-04-01 | PHASE4 |
| NCT04623840 | UNKNOWN | Erectile Dysfunction |
Cairo University |
2020-10-12 | |
| NCT04703127 | UNKNOWN | Premature Ejaculation |
Sohag University |
2020-03-30 | PHASE3 |
| NCT03641846 | COMPLETED | Erectile Dysfunction; Low Intensity Shockwave Therapy |
Institute for the Study of Urological Diseases, Greece |
2018-08-28 | |
| NCT04361305 | UNKNOWN | Premature Ejaculation; Erectile Dysfunction |
Yan-Ping Huang |
2020-06-03 | PHASE3 |
| NCT02611258 | COMPLETED | Cushing's Syndrome Cardiomyopathy |
Andrea M. Isidori |
2016-07 | PHASE2 |
| NCT02611336 | COMPLETED | Acromegaly Cardiomyopathy |
Andrea M. Isidori |
2016-07 | PHASE2 |
| NCT04235270 | COMPLETED | Healthy |
Janssen Research & Development, LLC |
2020-01-17 | PHASE1 |
| NCT05043896 | COMPLETED | Erectile Dysfunction |
Dr. Soetomo General Hospital |
2019-12-10 | |
| NCT02819440 | COMPLETED | Healthy; Obese |
Vanderbilt University Medical Center |
2016-07 | PHASE2 |
| NCT04946162 | WITHDRAWN | COVID; Sars-CoV2; ARDS, Human |
Santa Barbara Cottage Hospital |
2020-04-20 | PHASE4 |
| NCT03166787 | TERMINATED | Smoking; Endothelial Dysfunction |
Cedars-Sinai Medical Center |
2017-08-15 | PHASE1 |
| NCT02891850 | COMPLETED | Pulmonary Arterial Hypertension |
Bayer |
2017-01-11 | PHASE4 |
| NCT03566914 | COMPLETED | Cirrhosis |
Institute of Liver and Biliary Sciences, India |
2018-06-30 | |
| NCT03905018 | UNKNOWN | Obesity and Erectile Dysfuntion |
Centro Universitario de Ciencias de la Salud, Mexico |
2019-05-01 | PHASE3 |
| NCT01970176 | COMPLETED | Cardiomyopathy; Renal Impairment |
Mayo Clinic |
2014-01-09 | PHASE1; PHASE2 |
| NCT01862536 | COMPLETED | Pulmonary Hypertension; Chronic Obstructive Pulmonary Disease (COPD) |
VA Office of Research and Development |
2013-10-01 | PHASE2 |
| NCT02558231 | COMPLETED | Pulmonary Arterial Hypertension |
Actelion |
2016-05-01 | PHASE3 |
| NCT03238365 | COMPLETED | Lip, Oral Cavity and Pharynx; Larynx |
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University |
2017-08-10 | EARLY_PHASE1 |
| NCT01858558 | COMPLETED | Multiple Myeloma |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
2013-09 | PHASE2 |
| NCT02544880 | COMPLETED | Head and Neck Squamous Cell Carcinoma; Head and Neck Cancer |
Donald T. Weed, MD, FACS |
2016-04-25 | PHASE1 |
| NCT02058095 | COMPLETED | Cardiomyopathy; Renal Impairment |
Mayo Clinic |
2014-03 | PHASE1; PHASE2 |
| NCT01824290 | COMPLETED | Hypertension, Pulmonary |
Eli Lilly and Company |
2014-02-05 | PHASE3 |
| NCT02252367 | COMPLETED | Prostatic Hyperplasia; Lower Urinary Tract Symptoms |
University of Florence |
2015-12 | PHASE4 |
| NCT02601989 | COMPLETED | Diabetes Mellitus, Type 2 |
Göteborg University |
2015-11 | PHASE2 |
| NCT01803828 | COMPLETED | Diabetic Cardiomyopathy; Diabetes Mellitus Type 2 |
University of Roma La Sapienza |
2014-05 | PHASE4 |
| NCT02225548 | UNKNOWN | Parkinson's Disease; Erectile Dysfunction |
University of South Florida |
2014-09 | PHASE4 |
| NCT04446598 | COMPLETED | Chronic Prostatitis With Chronic Pelvic Pain Syndrome; Prostatodynia |
Adrian Gaspar |
2017-03-13 | |
| NCT03309592 | WITHDRAWN | Portopulmonary Hypertension; Pulmonary Hypertension; Cirrhosis, Liver |
Ochsner Health System |
2017-10-12 | PHASE4 |
| NCT03834610 | COMPLETED | Erectile Dysfunction |
Aswan University Hospital |
2017-10-01 | |
| NCT02968901 | TERMINATED | Pulmonary Arterial Hypertension |
Actelion |
2015-09-01 | PHASE4 |
| NCT02653833 | TERMINATED | Muscular Dystrophy |
Cedars-Sinai Medical Center |
2017-11-01 | EARLY_PHASE1 |
| NCT02450253 | COMPLETED | Dementia, Vascular |
St George's, University of London |
2015-09 | PHASE2 |
| NCT01903083 | COMPLETED | Locally Advanced Malignant Neoplasm |
Providence Health & Services |
2013-07 | PHASE1 |
| NCT01960153 | WITHDRAWN | Heart Failure; Pulmonary Hypertension |
Massachusetts General Hospital |
2013-10 | PHASE3 |
| NCT03215966 | COMPLETED | Healthy Subjects |
Actelion |
2017-08-07 | PHASE1 |
| NCT03236818 | UNKNOWN | Pulmonary Arterial Hypertension |
Amsterdam UMC, location VUmc |
2013-05 | PHASE4 |
| NCT02801032 | COMPLETED | Stroke, Lacunar; Cerebral Small Vessel Diseases |
Christina Kruuse |
2016-11-29 | PHASE2 |
| NCT02688387 | COMPLETED | Hypertension, Pulmonary |
GlaxoSmithKline |
2016-03-18 | PHASE1 |
| NCT03240939 | COMPLETED | Benign Prostatic Hyperplasia |
Yuyu Pharma, Inc. |
2017-03-27 | PHASE1 |
| NCT02943356 | UNKNOWN | Erectile Dysfunction; Andropause |
The Catholic University of Korea |
2016-07 | PHASE4 |
| NCT01484431 | COMPLETED | Pulmonary Arterial Hypertension |
Eli Lilly and Company |
2012-07-17 | PHASE1; PHASE2 |
| NCT01275339 | TERMINATED | Aortic Stenosis; LV Remodeling, Hypertrophy |
Washington University School of Medicine |
2012-12 | PHASE4 |
| NCT02862483 | UNKNOWN | Benign Prostatic Hyperplasia; Erectile Dysfunction |
IlDong Pharmaceutical Co Ltd |
2016-03 | PHASE3 |
| NCT02839122 | COMPLETED | Benign Prostate Hyperplasia |
Yuyu Pharma, Inc. |
2016-05 | PHASE1 |
| NCT02224846 | COMPLETED | Erectile Dysfunction |
Eli Lilly and Company |
2014-10 | PHASE4 |
| NCT03246880 | COMPLETED | Benign Prostatic Hyperplasia |
Chong Kun Dang Pharmaceutical |
2015-09 | PHASE3 |
| NCT02431754 | COMPLETED | Benign Prostatic Hyperplasia |
Eli Lilly and Company |
2015-04 | PHASE4 |
| NCT01937871 | COMPLETED | Benign Prostate Hyperplasia; Erectile Dysfunction |
Eli Lilly and Company |
2013-09 | PHASE3 |
| NCT01865084 | TERMINATED | Muscular Dystrophy, Duchenne |
Eli Lilly and Company |
2013-09 | PHASE3 |
| NCT02595684 | COMPLETED | Obesity |
University of Guadalajara |
2015-08 | PHASE4 |
| NCT01067391 | COMPLETED | Hypotension; Spinal Cord Injury |
University of Manitoba |
2009-10 | PHASE4 |
| NCT02554045 | COMPLETED | Obesity; Sexual Dysfunction |
University of Roma La Sapienza |
2015-01 | PHASE4 |
| NCT01661595 | COMPLETED | Fatigue |
The University of Texas Medical Branch, Galveston |
2012-11 | |
| NCT00843635 | COMPLETED | Head and Neck Cancer |
Donald T. Weed |
2008-09 | |
| NCT02300259 | COMPLETED | Healthy Volunteers |
Eli Lilly and Company |
2014-11 | PHASE1 |
| NCT02194465 | COMPLETED | Primary Hypertension |
Eli Lilly and Company |
2014-08 | PHASE2 |
| NCT01042158 | COMPLETED | Pulmonary Arterial Hypertension; Systemic Sclerosis; Scleroderma Spectrum of Diseases; Connective Tissue Disease; Pulmonary Hypertension |
Johns Hopkins University |
2010-01 | PHASE4 |
| NCT02247518 | COMPLETED | Healthy |
Chong Kun Dang Pharmaceutical |
2014-09 | PHASE1 |
| NCT02247505 | COMPLETED | Healty Male Volunteers |
Chong Kun Dang Pharmaceutical |
2014-09 | PHASE1 |
| NCT01305252 | COMPLETED | Hypertension, Pulmonary |
Stanford University |
2010-07 | PHASE4 |
| NCT02239484 | COMPLETED | Erectile Dysfunction; Benign Prostatic Hyperplasia |
Hanmi Pharmaceutical Company Limited |
2014-03 | PHASE1 |
| NCT01178073 | COMPLETED | Hypertension, Pulmonary |
GlaxoSmithKline |
2010-10-01 | PHASE3 |
| NCT01697800 | COMPLETED | Head and Neck Squamous Cell Carcinoma |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
2012-09 | PHASE2 |
| NCT01553981 | COMPLETED | Lung Diseases, Interstitial |
Sanjay Gandhi Postgraduate Institute of Medical Sciences |
2012-03 | PHASE3 |
| NCT01910389 | TERMINATED | Heart Failure; Pulmonary Hypertension |
Carelon Research |
2013-11 | PHASE3 |
| NCT01291069 | COMPLETED | Single Ventricle |
University of Utah |
2011-09 | PHASE1 |
| NCT01374217 | TERMINATED | Multiple Myeloma |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
2012-04 | PHASE2 |
| NCT01942551 | COMPLETED | Benign Prostate Hyperplasia |
Dongkook Pharmaceutical Co., Ltd. |
2013-09 | PHASE1 |
| NCT01326117 | WITHDRAWN | Gastroparesis; Diabetic Gastroparesis; Nausea; Vomiting |
Mark Feinglos |
2011-04 | PHASE4 |
| NCT01544998 | COMPLETED | Congestive Heart Failure |
Mayo Clinic |
2012-02 | PHASE1; PHASE2 |
| NCT01324999 | COMPLETED | Pulmonary Hypertension |
University of North Carolina, Chapel Hill |
2011-03 | PHASE2; PHASE3 |
| NCT01359670 | COMPLETED | Duchenne Muscular Dystrophy |
Cedars-Sinai Medical Center |
2011-05 | EARLY_PHASE1 |
| NCT01444651 | COMPLETED | Cardiovascular Disease; Insulin Resistance; Glucose Intolerance; Obesity |
Thomas J. Wang, MD |
2011-08 | PHASE3 |
| NCT01580501 | COMPLETED | Duchenne Muscular Dystrophy |
Cedars-Sinai Medical Center |
2012-03 | PHASE1 |
| NCT00931528 | COMPLETED | Prostate Cancer; Sexual Dysfunction |
Radiation Therapy Oncology Group |
2009-11 | PHASE3 |
| NCT01070511 | COMPLETED | Becker Muscular Dystrophy |
Cedars-Sinai Medical Center |
2010-01 | PHASE4 |
| NCT01026818 | COMPLETED | Erectile Dysfunction |
Eli Lilly and Company |
2009-11 | PHASE4 |
| NCT01460342 | COMPLETED | Benign Prostatic Hyperplasia |
Eli Lilly and Company |
2011-12 | PHASE3 |
| NCT01197469 | COMPLETED | Chronic Obstructive Pulmonary Disease; Pulmonary Hypertension |
University of Dundee |
2010-09 | PHASE2 |
| NCT01152190 | COMPLETED | Benign Prostatic Hyperplasia |
Eli Lilly and Company |
2010-09 | PHASE3 |
| NCT01352507 | COMPLETED | Erectile Dysfunction |
Eli Lilly and Company |
2011-06 | PHASE4 |
| NCT01364701 | UNKNOWN | Erectile Dysfunction |
Rambam Health Care Campus |
2011-06 | PHASE4 |
| NCT01342224 | COMPLETED | Locally Advanced Pancreatic Adenocarcinoma |
Providence Health & Services |
2011-01 | PHASE1 |
| NCT01743911 | COMPLETED | Hypertension |
University of Campinas, Brazil |
2010-09 | |
| NCT01302444 | TERMINATED | Pulmonary Arterial Hypertension |
Rhode Island Hospital |
2011-03 | PHASE4 |
| NCT00894413 | COMPLETED | Head and Neck Squamous Cell Carcinoma |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
2007-05-08 | PHASE2 |
| NCT00549302 | COMPLETED | Hypertension, Pulmonary |
Eli Lilly and Company |
2005-12 | PHASE3 |
| NCT01139762 | COMPLETED | Benign Prostatic Hyperplasia; Enlarged Prostate |
Eli Lilly and Company |
2010-09 | PHASE3 |
| NCT01130532 | COMPLETED | Erectile Dysfunction |
Eli Lilly and Company |
2010-08 | PHASE4 |
| NCT01238224 | TERMINATED | Type 2 Diabetes |
Vastra Gotaland Region |
2009-11 | PHASE1 |
| NCT01160289 | COMPLETED | Erectile Dysfunction |
Eli Lilly and Company |
2010-10 | PHASE2 |
| NCT01401543 | COMPLETED | Erectile Dysfunction |
Eli Lilly and Company |
2011-07 | PHASE1 |
| NCT01122264 | COMPLETED | Erectile Dysfunction |
Eli Lilly and Company |
2010-05 | PHASE4 |
| NCT01272388 | TERMINATED | Aortic Stenosis |
Washington University School of Medicine |
2011-01 | PHASE4 |
| NCT01183650 | COMPLETED | Benign Prostatic Hyperplasia |
Eli Lilly and Company |
2010-07 | PHASE1 |
| NCT00617305 | COMPLETED | Pulmonary Arterial Hypertension |
Gilead Sciences |
2008-04 | PHASE4 |
| NCT00970632 | COMPLETED | Benign Prostatic Hyperplasia (BPH) |
Eli Lilly and Company |
2009-10 | PHASE3 |
| NCT01244620 | TERMINATED | Pulmonary Arterial Hypertension |
Pfizer |
2010-11 | PHASE1 |
| NCT01060969 | COMPLETED | Pulmonary Edema; Cerebral Edema |
Sheba Medical Center |
2006-01 | |
| NCT00855582 | COMPLETED | Erectile Dysfunction; Benign Prostatic Hyperplasia |
Eli Lilly and Company |
2009-03 | PHASE3 |
| NCT01200732 | COMPLETED | Eisenmenger Syndrome |
Govind Ballabh Pant Hospital |
2008-02 | PHASE2 |
| NCT00861757 | COMPLETED | Benign Prostatic Hyperplasia |
Eli Lilly and Company |
2009-03 | PHASE3 |
| NCT01117298 | COMPLETED | Raynaud's Phenomenon; Digital Ulcers; Scleroderma |
Sanjay Gandhi Postgraduate Institute of Medical Sciences |
2009-11 | PHASE3 |
| NCT00822354 | COMPLETED | Raynaud |
Northwestern University |
2008-09 | |
| NCT00506701 | WITHDRAWN | Chronic Obstructive Lung Disease |
Herlev Hospital |
2008-02 | |
| NCT00705588 | UNKNOWN | Pulmonary Arterial Hypertension |
Rabin Medical Center |
2008-08 | PHASE4 |
| NCT00836693 | COMPLETED | Erectile Dysfunction |
Eli Lilly and Company |
2009-01 | PHASE3 |
| NCT00848081 | COMPLETED | Benign Prostatic Hyperplasia |
Eli Lilly and Company |
2009-03 | PHASE3 |
| NCT00827242 | COMPLETED | Benign Prostatic Hyperplasia |
Eli Lilly and Company |
2009-01 | PHASE3 |
| NCT00734604 | COMPLETED | Erectile Dysfunction |
Eli Lilly and Company |
2008-08 | PHASE3 |
| NCT00538564 | WITHDRAWN | Sickle Cell Anemia; Priapism |
Johns Hopkins University |
2006-11 | PHASE2 |
| NCT00783094 | COMPLETED | Benign Prostatic Hyperplasia |
Eli Lilly and Company |
2008-11 | PHASE2 |
| NCT00833638 | COMPLETED | Erectile Dysfunction |
Eli Lilly and Company |
2009-02 | PHASE4 |
| NCT00750308 | COMPLETED | Metabolic Syndrome |
Vanderbilt University |
2006-12 | |
| NCT00540124 | COMPLETED | Benign Prostatic Hyperplasia |
Eli Lilly and Company |
2007-10 | PHASE2 |
| NCT00386009 | COMPLETED | Benign Prostatic Hyperplasia |
Eli Lilly and Company |
2006-10 | PHASE2 |
| NCT00626665 | COMPLETED | Raynaud Disease |
Sanjay Gandhi Postgraduate Institute of Medical Sciences |
2007-12 | PHASE3 |
| NCT00422734 | COMPLETED | Impotence |
Eli Lilly and Company |
2006-11 | PHASE3 |
| NCT00384930 | COMPLETED | Benign Prostatic Hyperplasia |
Eli Lilly and Company |
2006-08 | PHASE2; PHASE3 |
| NCT00125918 | COMPLETED | Pulmonary Hypertension |
Eli Lilly and Company |
2005-08 | PHASE3 |
| NCT02253862 | COMPLETED | Healthy |
Boehringer Ingelheim |
2005-12 | PHASE1 |
| NCT00663130 | COMPLETED | Erectile Dysfunction |
Bayer |
2004-04 | PHASE4 |
| NCT00668109 | COMPLETED | Erectile Dysfunction |
Bayer |
2003-12 | PHASE3 |
| NCT00707187 | COMPLETED | Systemic Sclerosis |
University of Medicine and Dentistry of New Jersey |
2001-07 | PHASE2 |
| NCT00547495 | COMPLETED | Impotence |
Eli Lilly and Company |
2004-03 | PHASE3 |
| NCT00644956 | COMPLETED | Erectile Dysfunction |
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. |
2003-06 | PHASE4 |
| NCT00174486 | COMPLETED | Impotence |
Pfizer |
2005-02 | PHASE2 |
| NCT00422578 | COMPLETED | Impotence; Erectile Dysfunction |
Eli Lilly and Company |
2004-10 | PHASE4 |
| NCT00547573 | COMPLETED | Impotence |
Eli Lilly and Company |
2003-04 | PHASE3 |
| NCT00334477 | UNKNOWN | Erectile Dysfunction |
University of Pernambuco |
PHASE2 | |
| NCT00463957 | UNKNOWN | Erectile Dysfunction |
University of Cambridge |
2006-08 | |
| NCT00333281 | COMPLETED | Erectile Dysfunction |
Eli Lilly and Company |
2005-06 | PHASE4 |
| NCT00381732 | COMPLETED | Erectile Dysfunction |
Eli Lilly and Company |
2003-10 | PHASE3 |
| NCT00547183 | COMPLETED | Impotence |
Eli Lilly and Company |
2004-10 | PHASE3 |
| NCT00157326 | COMPLETED | Hypertension |
Eli Lilly and Company |
2005-09 | PHASE2 |
| NCT00382135 | COMPLETED | Erectile Dysfunction |
Eli Lilly and Company |
2003-11 | PHASE4 |
| NCT00547352 | COMPLETED | Impotence |
Eli Lilly and Company |
2004-06 | PHASE4 |
| NCT00547599 | COMPLETED | Impotence |
Eli Lilly and Company |
2003-04 | PHASE4 |
| NCT00050609 | COMPLETED | Gastroparesis |
Eli Lilly and Company |
2003-02 | PHASE2 |
| NCT00547417 | COMPLETED | Impotence |
Eli Lilly and Company |
2003-07 | PHASE3 |
| NCT00547092 | COMPLETED | Impotence |
Eli Lilly and Company |
2003-10 | PHASE4 |
| NCT00215631 | TERMINATED | Prostate Cancer; Erectile Dysfunction |
Erasmus Medical Center |
2005-10 | PHASE3 |
| NCT00547508 | COMPLETED | Impotence |
Eli Lilly and Company |
2002-10 | PHASE3 |
| NCT00122499 | COMPLETED | Prostate Cancer; Erectile Dysfunction |
Erasmus Medical Center |
2003-02 | PHASE3 |
| NCT00274430 | COMPLETED | High Altitude Pulmonary Edema |
University of Zurich |
2003-07 | PHASE1; PHASE2 |
| NCT00421083 | COMPLETED | Erectile Dysfunction; Spinal Cord Injuries |
Eli Lilly and Company |
2004-09 | PHASE3 |
| NCT00547625 | COMPLETED | Prostatic Hyperplasia; Prostate |
Eli Lilly and Company |
2004-10 | PHASE2 |
| NCT00547287 | COMPLETED | Impotence |
Eli Lilly and Company |
2002-11 | PHASE3 |
(data from https://clinicaltrials.gov, updated on 2026-05-15)
Check the
Tadalafil
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
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>).
Note: Technical data last updated: Sep 1, 2026.