Cialis

(Tadalafil)

ApprovedSmall molecule

Tadalafil is used to treat erectile dysfunction (difficulty getting or maintaining an erection) in men, and also to treat high blood pressure in the lungs and enlarged prostate symptoms.[2] Cialis is currently approved and in use across 42 indications[4].[1]

Cialis is one of 682 small molecule programs targeting Single Dose. It is currently in Approved.

Indications

198

Total Trials

Active Trials

681

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Single DoseNot yet recruiting

Eisenmenger SyndromeApproved

Raynaud DiseaseApproved

Major Depressive DisorderApproved

Anaplastic AstrocytomaApproved

ImpotenceApproved

Type 2 Diabetes MellitusApproved

Vascular DementiaApproved

Essential HypertensionApproved

Transposition of the Great ArteriesApproved

Single DosePhase 1

Not yet recruiting

Eisenmenger SyndromeApproved

Approved

Raynaud DiseaseApproved

Approved

Major Depressive DisorderApproved

Approved

Anaplastic AstrocytomaApproved

Approved

ImpotenceApproved

Approved

Type 2 Diabetes MellitusApproved

Approved

Vascular DementiaApproved

Approved

Essential HypertensionApproved

Approved

Transposition of the Great ArteriesApproved

Approved

Showing 10 of 41 indications

Competition

Competitive Landscape

335 competitors in Pancreatic Cancer

#DrugCompanyPhaseTrials

Cialis

Eli Lilly

Approved

2 2

Byetta

AstraZeneca

Preclinical

1 3

Ayvakit Sprinkle

MMemorial Sloan Kettering Cancer Center

Preclinical

1 4

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

1 5

Xylocaine

MMEDRx USA, Inc.

Preclinical

1 6

Feraheme

AAzurity Pharmaceuticals

Preclinical

1 7

Active Comparator

Moderna

Preclinical

1 8

Sulfonylureas

Eli Lilly

Preclinical

1 9

HB-Admscs

HHope Biosciences Research Foundation

Preclinical

1 10

Cyclophosphamid

EEssen Biotech

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Active, not recruiting

Gastric Adenocarcinoma

NCT05709574

Phase 2Recruiting

Exercise

NCT06290713

Phase 3Recruiting

Fontan

NCT05206955

Phase 3Not yet recruiting

Erectile Dysfunction

NCT07177326

Post-ApprovalRecruiting

Overactive Bladder

NCT07416968

Q1 2027

ApprovedRecruiting

Prediabetes

NCT05051436

Clinical

Trials by Indication[1]

Erectile Dysfunction36 trials

A Study to Evaluate the Efficacy and Safety of 2.5mg and 5mg Tadalafil Given Once a Day to Men With Erectile Dysfunction

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00381732·280 enrolled

A Study of LY900010 in Erectile Dysfunction

Completed· Eli Lilly logo

Eli Lilly·Phase 2·NCT01160289·410 enrolled

Sagene 2014 - Parkinson's Disease and Erectile Dysfunction

Unknown status·UUniversity of South Florida·Phase 4·NCT02225548·10 enrolled

Show 33 more trials

A Study of Tadalafil and Sildenafil in Men With Erectile Dysfunction in China

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT01352507·383 enrolled

A Randomized, Open-Label, Crossover, Multicenter, Single Dose Comparator Study Evaluating Onset Of Penile Rigidity In Men With Erectile Dysfunction Who Are Treated With Sildenafil And Tadalafil

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 4·NCT00644956·56 enrolled

A Study of Visual Effects of Erectile Dysfunction Medications Dosed Daily for Six Months

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT00333281·198 enrolled

A Study in Patients With Erectile Dysfunction

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT01122264·770 enrolled

Safety And Efficacy Of L-Arginine Monotherapy Versus Tadalafil Monotherapy Versus Their Combination In Men With Erectile Dysfunction; A Prospective Randomized Study

Completed·FFayoum University Hospital·Phase 4·NCT06947265·180 enrolled

Effect of Tadalafil Once a Day in Men With Erectile Dysfunction

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00836693·217 enrolled

Effect of Tadalafil on the Quality of Life and Sexual Life in Erectile Dysfunction

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT00422578·200 enrolled

A Study in Erectile Dysfunction

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT01130532·623 enrolled

Endocan Level in Patients With Erectile Dysfunction and Relationship With Tadalafil Treatment

Unknown status·—·N/A·NCT05109377·90 enrolled

A Study in the Treatment of Erectile Dysfunction and Benign Prostate Hyperplasia

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00855582·606 enrolled

A Study in Erectile Dysfunction

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT00833638·372 enrolled

A Study of Tadalafil (LY450190) in Chinese Men With Erectile Dysfunction

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT02224846·635 enrolled

Effect of Tadalafil on Erectile Dysfunction Treatment and QOL Improvement Effect (by SF-12) in Andropause Patients With Erectile Dysfunction

Unknown status·TThe Catholic University of Korea·Phase 4·NCT02943356·40 enrolled

Shock Wave vs. On-demand Tadalafil for Erectile Dysfunction

Unknown status·MMenoufia University·N/A·NCT05199727·50 enrolled

Daily Oral L-arginine Plus Tadalafil in Diabetic Patients With Erectile Dysfunction

Completed·—·N/A·NCT03834610·108 enrolled

Genetic Factors of Erectile Dysfunction Degree and Response to Tadalafil Treatment in Patients With Diabetes

Recruiting·UUniversity Medical Centre Ljubljana·Phase 3·NCT06520839·90 enrolled

Evaluating the Efficacy Vardenafil 10 mg vs Tadalafil 10 mg in in Subjects With Erectile Dysfunction (ED)

Completed· Bayer logo

Bayer·Phase 4·NCT00663130·759 enrolled

Clinical Investigation Using MED3000 Gel or Tadalafil Tablets in the Treatment of Erectile Dysfunction

Completed·FFutura Medical Developments Ltd.·Phase 3·NCT04984993·116 enrolled

Combination Therapy of Tadalafil 2.5mg Plus Sildenafil 25mg Versus Tadalafil 5 mg Monotherapy for Treatment of Erectile Dysfunction: A Randomized, Placebo-Controlled Double-Blinded Cross-Over Study

Not yet recruiting·—·Phase 3·NCT07177326·142 enrolled

Tadalafil for Erectile Dysfunction in Patients With Cirrhosis

Completed·IInstitute of Liver and Biliary Sciences, India·N/A·NCT03566914·140 enrolled

Evaluation of Tadalafil Combined With LIPUS for Treating Erectile Dysfunction

Completed·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·N/A·NCT06543628·114 enrolled

Serum YKL-40 Level and Platelets Indices Among Patients With Diabetic Erectile Dysfunction

Completed·—·Phase 4·NCT05446493·60 enrolled

Evaluation of Efficacy of Botulinum Toxin A Plus Oral Tadalafil 5 mg in Diabetic Men With Erectile Dysfunction

Recruiting·—·Phase 2/3·NCT06583590·32 enrolled

Efficacy and Safety of Tadalafil in Subjects With Erectile Dysfunction Caused by Spinal Cord Injury

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00421083·180 enrolled

Tadalafil in Preventing Erectile Dysfunction in Patients With Prostate Cancer Treated With Radiation Therapy

Completed· Radiation Therapy Oncology Group logo

Radiation Therapy Oncology Group·Phase 3·NCT00931528·242 enrolled

A Study to Assess the Efficacy of Tadalafil to Treat Erectile Dysfunction After Radiotherapy of Prostate Cancer

Completed·EErasmus Medical Center·Phase 3·NCT00122499

Assessment of Efficacy of Vardenafil in Subjects With Erectile Dysfunction and Diabetes, Hypertension or Hyperlipidemia

Completed· Bayer logo

Bayer·Phase 3·NCT00668109·614 enrolled

Efficacy of Transcutaneous Electrical Neural Stimulation and Tadalafil in Men With Erectile Dysfunction: A Randomized, Double-Blind, Bi-centric, Placebo- and Sham-Controlled Trial

Completed·MMenoufia University·Approved·NCT07574268·185 enrolled

Investigation of the Effect of the Atherogenic Index on the Therapeutic Response to Tadalafil in Patients With Vascular Erectile Dysfunction

Completed·TTaksim Egitim ve Arastirma Hastanesi··NCT07479901·176 enrolled

Efficacy of Daily 5-mg Tadalafil as Adjunctive Therapy Versus Monotherapy in Men With On-Demand PDE5 Inhibitor-Resistant Erectile Dysfunction: A Prospective Randomized Trial

Recruiting·AAl-Azhar University·Approved·NCT07753720·260 enrolled

Endothelial Dysfunction Markers as Predictors of Clinical Response to Daily Tadalafil in Men With Vasculogenic Erectile Dysfunction

Recruiting·AAl-Azhar University··NCT07773103·120 enrolled

Clinical Efficacy of Intracavernosal Xeomin as an Adjunctive Therapy to on Demand Tadalafil 20 mg for the Treatment of Mild to Moderate Erectile Dysfunction: A Randomized Crossover Pilot Study

Not yet recruiting·NNorthwestern University·Phase 2·NCT07537855·30 enrolled

Comparison Between The Effect of Intracavernosal Injection of Platelet-Rich Plasma as a Single Agent vs Daily Oral 5 Phosphodiesterase Inhibitor Intake as a Single Agent Vs Combination In Improving of Erectile Dysfunction

Completed·AAin Shams University·Preclinical·NCT07761806·75 enrolled

Benign Prostatic Hyperplasia19 trials

A Study of Tadalafil in Benign Prostatic Hyperplasia

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT01183650·24 enrolled

Effects of Tadalafil Once a Day for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia

Completed· Eli Lilly logo

Eli Lilly·Phase 2·NCT00386009·200 enrolled

A Study of Tadalafil in Men With Benign Prostatic Hyperplasia Symptoms Who Are Being Treated With Alpha Blockers

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00848081·318 enrolled

Show 16 more trials

A Study in Benign Prostatic Hyperplasia

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT01152190·97 enrolled

Study to Treat Patients Who Have Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) With Tadalafil Daily

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00827242·325 enrolled

Phase 3 Study of Tadalafil Once-Daily in Asian Men With Benign Prostatic Hyperplasia (BPH)

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT01460342·610 enrolled

Pilot Study Investigating Safety and Efficacy of Tadalafil as Treatment for Benign Prostatic Hyperplasia (BPH) in Asian Men

Completed· Eli Lilly logo

Eli Lilly·Phase 2·NCT00540124·151 enrolled

A Study of Tadalafil (LY450190) in Participants With Lower Urinary Tract Symptoms (LUTS) Suggestive of Benign Prostatic Hyperplasia LUTS (BPH-LUTS).

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT02431754·171 enrolled

Administration of Tadalafil in Patients With Benign Prostatic Hyperplasia

Completed·—·Phase 3·NCT06466369·306 enrolled

Study of Tadalafil Once-a Day for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia

Completed· Eli Lilly logo

Eli Lilly·Phase 2/3·NCT00384930·1,058 enrolled

Efficacy and Safety of DKF-313 in Patients With Benign Prostatic Hyperplasia

Completed·DDongkook Pharmaceutical Co., Ltd.·Phase 3·NCT04947631·667 enrolled

Comparison Between Tamsulosin and Tadalafil in Management of Benign Prostatic Hyperplasia Long Term Study

Completed·MMansoura University·Phase 4·NCT05818670·160 enrolled

A Study of Tadalafil in Men With Benign Prostatic Hyperplasia (BPH) and Erectile Dysfunction (ED)

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT01937871·909 enrolled

A Study of Tadalafil in Men With Benign Prostatic Hyperplasia

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00970632·511 enrolled

Study of Tadalafil Once-a-Day for 12 Weeks in Japanese Men With Benign Prostatic Hyperplasia Followed by an Open-Label Extension

Completed· Eli Lilly logo

Eli Lilly·Phase 2·NCT00783094·422 enrolled

Clinical Trial To Evaluate the Efficacy and Safety of CKD-397 in Benign Prostatic Hyperplasia Patients

Completed· Chong Kun Dang Pharmaceutical logo

Chong Kun Dang Pharmaceutical·Phase 3·NCT03246880·455 enrolled

The Efficacy and Safety of the Combination of Tamsulosin and Tadalafil in Men With Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia and Erectile Dysfunction

Unknown status· IlDong Pharmaceutical Co Ltd logo

IlDong Pharmaceutical Co Ltd·Phase 3·NCT02862483·330 enrolled

Multinational Study to Evaluate Tadalafil in Asian Men With Signs and Symptoms of Benign Prostatic Hyperplasia

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00861757·612 enrolled

"Effect of Different Dosing Regimens of Tadalafil or Tamsulosin Combined With 5α-Reductase Inhibitors on Urinary and Sexual Outcomes in Benign Prostatic Hyperplasia: A Comparative Clinical Trial Study"

Completed·BBeni-Suef University·Approved·NCT07715448·240 enrolled

Pulmonary Arterial Hypertension9 trials

Post Marketing Observational Study in Patients With Pulmonary Arterial Hypertension

Completed· Eli Lilly logo

Eli Lilly··NCT01066845·1,809 enrolled

Acute Haemodynamic Study of TPN171H in Patients with Pulmonary Arterial Hypertension

Completed·VVigonvita Life Sciences·Phase 2·NCT04483115·60 enrolled

Study of Add-on Ambrisentan Therapy to Background Phosphodiesterase Type-5 Inhibitor (PDE5i) Therapy in Pulmonary Arterial Hypertension (ATHENA-1)

Completed· Gilead logo

Gilead·Phase 4·NCT00617305·38 enrolled

Show 6 more trials

PHIRST-1: Tadalafil in the Treatment of Pulmonary Arterial Hypertension

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00125918·406 enrolled

A Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH)

Completed· GSK logo

GSK·Phase 3·NCT01178073·610 enrolled

A Study of Tadalafil in Pediatric Participants With Pulmonary Arterial Hypertension (PAH)

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT01824290·35 enrolled

The Efficacy and Safety of Initial Triple Versus Initial Dual Oral Combination Therapy in Patients With Newly Diagnosed Pulmonary Arterial Hypertension

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT02558231·247 enrolled

Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed-dose Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH)

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT03904693·187 enrolled

Clinical Study Evaluating the Effects of First-line Oral cOmbination theraPy of maciTentan and tadalafIl in Patients With Newly Diagnosed pulMonary Arterial Hypertension (OPTIMA)

Terminated· Johnson & Johnson logo

Johnson & Johnson·Phase 4·NCT02968901·46 enrolled

Pulmonary Hypertension6 trials

Tadalafil for Sarcoidosis Associated Pulmonary Hypertension

Completed·UUniversity of North Carolina, Chapel Hill·Phase 2/3·NCT01324999·12 enrolled

Treprostinil Combined With Tadalafil for Pulmonary Hypertension

Terminated·RRhode Island Hospital·Phase 4·NCT01302444·1 enrolled

Long Acting Phosphodiesterase 5 Inhibitors as Add-on Therapy for Patients With Pulmonary Hypertension Treated With Prostanoids.

Unknown status·RRabin Medical Center·Phase 4·NCT00705588·30 enrolled

Show 3 more trials

Tadalafil for Pulmonary Hypertension Due to Chronic Lung Disease

Completed·VVA Office of Research and Development·Phase 2·NCT01862536·44 enrolled

Effect of Tadalafil in Chronic Obstructive Lung Disease Patients Suffering From Secondary Pulmonary Hypertension

Withdrawn·HHerlev Hospital·N/A·NCT00506701

Efficacy of Phosphodiesterase Type 5 Inhibitors in Severe Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease

Recruiting·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT05844462·200 enrolled

Effectiveness5 trials

Determine Safety and Effectiveness of Tadalafil in Asian Men When Taken as Needed for Getting and Keeping an Erection

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00547573·367 enrolled

Study the Safety and Effectiveness of Tadalafil in Men With Problems Getting or Maintaining an Erection When Taken Prior to Desiring an Erection

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00547495·343 enrolled

Study the Safety and Effectiveness of Tadalafil in Men With Diabetes Who Have Problems Getting and Keeping an Erection

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00547183·298 enrolled

Show 2 more trials

Study to Determine Safety and Effectiveness of Tadalafil on Prostate Related Sex Organ/Urinary Tract Problems

Completed· Eli Lilly logo

Eli Lilly·Phase 2·NCT00547625·275 enrolled

Evaluation of Safety and Effectiveness of 2 Lower Dose Combined PDE5i's Versus Single Maximal Dose PDE5i Treatment

Unknown status·RRambam Health Care Campus·Phase 4·NCT01364701·30 enrolled

82 more indications

Treatment4 trials

Study For Which Treatment, Tadalafil or Sildenafil, is Preferred For Problems Getting or Maintaining an Erection

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT00547092·386 enrolled

Tadalafil for the Treatment of Raynaud's

Completed·NNorthwestern University·N/A·NCT00822354·10 enrolled

Study to Determine a Preference Between Sildenafil or Tadalafil Treatment for Problems Getting an Erection

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT00547352·160 enrolled

Show 1 more trial

Study of Tadalafil for the Treatment of Diabetic Patients With Symptoms of Upset Stomach and Delayed Stomach Emptying

Completed· Eli Lilly logo

Eli Lilly·Phase 2·NCT00050609·2 enrolled

Lower Urinary Tract Symptom4 trials

Effect of 12 Weeks Treatment With Tadalafil vs Placebo on Lower Urinary Tract Symptoms

Completed·UUniversity of Florence·Phase 4·NCT02252367·86 enrolled

Efficacy and Safety of Tadalafil, Tamsulosin, and Their Combinations in Treating Lower Urinary Tract Symptoms in BPH Patients with Prostate Volumes ≤ 40 Ml: a Prospective Comparative Study

Completed·FFayoum University Hospital·Phase 4·NCT06809205·95 enrolled

Tadalafil 5 mg on Storage Lower Urinary Tract Symptoms After Anatomical Endoscopic Enucleation of the Prostate

Not yet recruiting·—·Phase 1·NCT07466030·40 enrolled

Show 1 more trial

Impact of Tadalafil 5 mg on Post-micturition Dribble in Young-age Men With no/Mild Lower Urinary Tract Symptoms

Unknown status·MMansoura University·N/A·NCT05146674·80 enrolled

Squamous Cell Carcinoma3 trials

A Trial of Tadalafil in Patients With Squamous Cell Carcinoma of the Upper Aero Digestive Tract

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT00894413·45 enrolled

A Phase II Trial of Tadalafil in Patients With Squamous Cell Carcinoma of the Upper Aero Digestive Tract

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT01697800·40 enrolled

Window of Opportunity Trial of Nivolumab and Tadalafil in Patients With Squamous Cell Carcinoma of the Head and Neck

Completed·SSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University·Phase 1·NCT03238365·50 enrolled

Cardiomyopathy3 trials

Study to Determine How Cialis Effects the Renal Function in Response to Volume Expansion in Preclinical Diastolic Cardiomyopathy (Aim3)

Completed·MMayo Clinic·Phase 1/2·NCT02058095·22 enrolled

Study to Determine How Cialis Effects the Renal Function in Response to Volume Expansion in Preclinical Systolic Cardiomyopathy (Aim2)

Completed·MMayo Clinic·Phase 1/2·NCT01970176·20 enrolled

Endocrine Cardiomyopathy: Response to Cyclic GMP PDE5 Inhibitors in Acromegaly Cardiomyopathy

Completed·—·Phase 2·NCT02611336·15 enrolled

Interaction3 trials

Safety and Pharmacokinetic Interaction Study of Tadalafil and Dutasteride

Completed·DDongkook Pharmaceutical Co., Ltd.·Phase 1·NCT01942551·47 enrolled

Evaluating a Pharmacokinetic Drug Interaction Between Tadalafil and Tamsulosin

Completed· Hanmi Pharmaceutical Company Limited logo

Hanmi Pharmaceutical Company Limited·Phase 1·NCT02239484·30 enrolled

A Pharmacokinetic Drug-Drug Interaction (DDI) Study Between Sitaxsentan And Sildenafil, And Between Sitaxsentan And Tadalafil After Multiple Doses

Terminated· Pfizer logo

Pfizer·Phase 1·NCT01244620·16 enrolled

Obesity3 trials

PDE5 Inhibition for Obesity-Related Cardiometabolic Dysfunction

Completed·VVanderbilt University Medical Center·Phase 2·NCT02819440·141 enrolled

Effect of Tadalafil Administration on Vasodilatation Mediated by Flow in Patients With Obesity Grade I-II

Unknown status·CCentro Universitario de Ciencias de la Salud, Mexico·Phase 3·NCT03905018·80 enrolled

Effect of PDE5 Inhibition on Adipose Metabolism in Humans

Completed·VVanderbilt University Medical Center·Phase 2·NCT04684589·99 enrolled

Single Dose3 trials

Perfusion by Arterial Spin Labelling Following Single Dose Tadalafil in Small Vessel Disease (PASTIS) Trial

Completed·SSt George's, University of London·Phase 2·NCT02450253·55 enrolled

Effects of Single Dose Tadalafil on Urethral and Anal Closure Function

Completed·UUniversity Hospital Bispebjerg and Frederiksberg·Phase 1·NCT05095077·24 enrolled

A Single Dose Randomized Five-Way Crossover Pharmacokinetics (PK) Study of Tadalafil Semi-Chewable (Gummy) Formulations in Healthy Volunteers

Not yet recruiting·SSeattle Gummy Company·Phase 1·NCT04762082·30 enrolled

Heart Failure3 trials

Phosphodiesterase Type 5 Inhibition With Tadalafil Changes Outcomes in Heart Failure: Extent of Renal Damage

Withdrawn·MMassachusetts General Hospital·Phase 3·NCT01960153

Tadalafil and Nesiritide as Therapy in Pre-clinical Heart Failure

Completed·MMayo Clinic·Phase 1/2·NCT01544998·43 enrolled

Phosphodiesterase Type 5 Inhibition With Tadalafil Changes Outcomes in Heart Failure

Terminated·CCarelon Research·Phase 3·NCT01910389·23 enrolled

Duchenne Muscular Dystrophy2 trials

A Study of Tadalafil for Duchenne Muscular Dystrophy

Terminated· Eli Lilly logo

Eli Lilly·Phase 3·NCT01865084·331 enrolled

Tadalafil and Sildenafil for Duchenne Muscular Dystrophy

Completed·—·Phase 1·NCT01359670·30 enrolled

Aortic Stenosis2 trials

Aortic Stenosis and PhosphodiEsterase Type 5 iNhibition (ASPEN): A Pilot Study

Terminated·WWashington University School of Medicine·Phase 4·NCT01275339·10 enrolled

Aortic Stenosis and PhosphodiEsterase iNhibition With Aortic Valve Replacement (ASPEN-AVR): A Pilot Study

Terminated·WWashington University School of Medicine·Phase 4·NCT01272388·1 enrolled

Scleroderma2 trials

Randomised Control Trial to Assess the Efficacy of Tadalafil in Raynaud's Phenomenon in Scleroderma

Completed·SSanjay Gandhi Postgraduate Institute of Medical Sciences·Phase 3·NCT00626665·25 enrolled

A Randomized Control Trial to Assess the Efficacy of Tadalafil in Raynaud's Phenomenon in Scleroderma

Completed·SSanjay Gandhi Postgraduate Institute of Medical Sciences·Phase 3·NCT01117298·66 enrolled

High Blood Pressure2 trials

Study the Safety and Effectiveness of Tadalafil on High Blood Pressure in the Blood Vessel Going From the Heart to the Lungs

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00549302·357 enrolled

A Study of LY2623091 in Participants With High Blood Pressure

Completed· Eli Lilly logo

Eli Lilly·Phase 2·NCT02194465·304 enrolled

Pancreatic Cancer2 trials

Chemoimmunotherapy and Radiation in Pancreatic Cancer

Completed·PProvidence Health & Services·Phase 1·NCT01903083·10 enrolled

Study of CRS-207, Pembrolizumab, Ipilimumab, and Tadalafil in Metastatic Pancreatic Cancer

Active, not recruiting·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT05014776·17 enrolled

Overactive Bladder2 trials

Solifenacin Plus Tadalafil vs Solifenacin Alone for Overactive Bladder in Females

Completed·—·N/A·NCT07312955·80 enrolled

Randomized Controlled Trial Comparing Low Dose Tadalafil Versus Solifenacin For Management of Overactive Bladder in Women: Multicenter Egyptian National Study

Recruiting·MMansoura University·Phase 4·NCT07416968·480 enrolled

Adult2 trials

A Study of Macitentan and Tadalafil as a Fixed Dose Combination and the Free Combination in Healthy Adult Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT04235270·62 enrolled

A Study of Fixed Dose Combination of Macitentan/Tadalafil (10 mg/20 mg) Compared to the Reference Free Combination of Macitentan and Tadalafil in Healthy Adult Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT05236231·40 enrolled

Combination Therapy2 trials

Comparison of Sequential to Initial Combination Therapy in PAH

Recruiting·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·N/A·NCT06968962·376 enrolled

Efficacy of Tadalafil/Solifenacin VS Tamsulosin/Solifenacin Combination Therapy for BPH/OAB

Unknown status·MMansoura University·Phase 4·NCT05494567·60 enrolled

Premature Ejaculation2 trials

Efficacy and Safety of Toronto Association in the Treatment of Erectile Dysfunction and Premature Ejaculation

Not yet recruiting·EEMS·Phase 3·NCT05052879·232 enrolled

Observational Study of Pharmacological Treatment for Premature Ejaculation Concurrent With Erectile Dysfunction

Unknown status·YYan-Ping Huang·Phase 3·NCT04361305·150 enrolled

Becker muscular dystrophy2 trials

Tadalafil in Becker Muscular Dystrophy

Completed·—·Phase 4·NCT01070511·48 enrolled

The Study of Skeletal Muscle Blood Flow in Becker Muscular Dystrophy

Terminated·—·Phase 1·NCT02653833·6 enrolled

Tics2 trials

Pharmacokinetics and Safety/Tolerability of YY-201 in Comparison to Dutasteride and Tadalafil

Completed·YYuyu Pharma, Inc.·Phase 1·NCT03240939·36 enrolled

A Study of Semen Characteristics After 9 Months of Daily Tadalafil 20 mg

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT00382135·282 enrolled

Oral2 trials

The Pharmacological Basis for the Increase in Visual Time Constants Induced by Single Oral Doses of Sildenafil

Unknown status·UUniversity of Cambridge·N/A·NCT00463957·12 enrolled

Population Pharmacokinetics and Dosage Individualization of Oral Pulmonary Vasodilators in PPHN

Unknown status·SShandong University··NCT04379180·500 enrolled

MPA2 trials

A Study to Compare the Macitentan-tadalafil Fixed Dose Combination Tablet Relative to the Concomitant Administration of the Reference Tablets of Macitentan and Tadalafil in Healthy Subjects

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT03215966·38 enrolled

A Study of Macitentan/Tadalafil Combination Administered a Fixed-dose Combination Formulation Compared to the Reference Free Combination of Macitentan and Tadalafil

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT04540744·18 enrolled

ART1 trial

A Study of LY2623091 in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT02300259·48 enrolled

Trial1 trial

A Trial of Tadalafil and Glycemic Traits

Completed·—·Phase 3·NCT01444651·73 enrolled

Dyspnea1 trial

Breathe Easier With Tadalafil Therapy for Dyspnea in COPD-PH

Recruiting·VVA Office of Research and Development·Phase 2·NCT05937854·126 enrolled

AIN1 trial

Riociguat rEplacing PDE-5i Therapy evaLuated Against Continued PDE-5i thErapy

Completed· Bayer logo

Bayer·Phase 4·NCT02891850·225 enrolled

Stress1 trial

Determine If the Stress That Comes With Not Developing an Erection Affects Tadalafil Effects

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT00547599·659 enrolled

Type 2 Diabetes1 trial

Effects of PDE-5 Inhibition on Postprandial Hyperglycemia in Type 2 Diabetes

Terminated·VVastra Gotaland Region·Phase 1·NCT01238224·22 enrolled

Non-Small Cell Lung Cancer1 trial

Marrow Infiltrating Lymphocytes - Non-Small Cell Lung Cancer (MILs™ - NSCLC) Alone or in Combination With Nivolumab With or Without Tadalafil in Locally Advanced and Unresectable or Metastatic NSCLC

Terminated·WWindMIL Therapeutics·Phase 2·NCT04069936·19 enrolled

Drug Interactions1 trial

A Study to Investigate the Pharmacokinetic Drug Interactions Between Dutasteride and Tadalafil in Healthy Male Subjects

Completed·YYuyu Pharma, Inc.·Phase 1·NCT02839122·28 enrolled

Fatigue1 trial

The Effect of Sildenafil and Tadalafil on Skeletal Muscle and Perceptual Fatigue

Completed·TThe University of Texas Medical Branch, Galveston·N/A·NCT01661595·30 enrolled

Cardiovascular1 trial

COMMODITIES Trial: Initial Dual Oral Therapy vs Monotherapy in PAH With Cardiovascular Comorbidities

Not yet recruiting·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT07245680·186 enrolled

Multiple Myeloma1 trial

Administration of Tadalafil in Conjunction With Lenalidomide and Dexamethasone in Patients With Multiple Myeloma

Terminated·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT01374217·14 enrolled

Prostatectomy1 trial

A Study of Tadalafil After Radical Prostatectomy

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT01026818·583 enrolled

Fibrinolysis1 trial

Renin Angiotensin Aldosterone System (RAAS) and Fibrinolysis in Humans: ACEi and PE5i

Completed·VVanderbilt University·N/A·NCT00750308·27 enrolled

Astrocytoma1 trial

Tadalafil to Overcome Immunosuppression During Chemoradiotherapy for IDH-wildtype Grade III-IV Astrocytoma

Completed·WWashington University School of Medicine·Phase 1·NCT04757662·18 enrolled

Stroke1 trial

Effect of Tadalafil on Cerebral Large Arteries in Stroke

Completed·CChristina Kruuse·Phase 2·NCT02801032·20 enrolled

Gastroparesis1 trial

Daily Tadalafil and Gastric Emptying Time in Diabetic Gastroparesis

Withdrawn·MMark Feinglos·Phase 4·NCT01326117

Prostate1 trial

A Study of Tadalafil Use With Finasteride in Men With Enlarged Prostates and Urinary Symptoms

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT01139762·696 enrolled

Chronic Obstructive Pulmonary Disease1 trial

Do Phosphodiesterase 5A Inhibitors Improve Exercise Capacity in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Pulmonary Hypertension?

Completed·UUniversity of Dundee·Phase 2·NCT01197469·120 enrolled

Function1 trial

The Effects of a Nitrate Supplementation on Erectile Function

Unknown status·RRHA Investments Ltd·N/A·NCT06213077·20 enrolled

Hypertension1 trial

Tadalafil in Subjects With Mild to Moderate Hypertension

Completed· Eli Lilly logo

Eli Lilly·Phase 2·NCT00157326·180 enrolled

Efficacy and Safety1 trial

Efficacy and Safety of Tadalafil in Hemodialysis Patients

Unknown status·UUniversity of Pernambuco·Phase 2·NCT00334477·60 enrolled

Efficacy1 trial

PDE5 Inhibition Via Tadalafil to Enhance Anti-Tumor Mucin 1 (MUC1) Vaccine Efficacy in Patients With HNSCC

Completed·—·Phase 1·NCT02544880·16 enrolled

Frozen Embryo Transfer1 trial

Effect of Tadalafil, Sildenafil and Pentoxyfylline on Frozen Embryo Transfer Outcomes

Unknown status·—·Phase 2/3·NCT05971667·200 enrolled

Exercise1 trial

Vasodilator and Exercise Study for DMD (VASO-REx)

Recruiting·UUniversity of Florida·Phase 2·NCT06290713·50 enrolled

Prostate Cancer1 trial

Can Tadalafil Maintain Erectile Function In Patients Treated With Radiotherapy For Prostate Cancer?

Terminated·EErasmus Medical Center·Phase 3·NCT00215631·100 enrolled

Cushing syndrome1 trial

Endocrine Cardiomyopathy in Cushing Syndrome: Response to Cyclic GMP PDE5 inhibitOrs

Completed·—·Phase 2·NCT02611258·18 enrolled

Adjuvant Therapy1 trial

Tadalafil as Adjuvant Therapy for DMD

Active, not recruiting·UUniversity of Florida·Phase 2/3·NCT05195775·25 enrolled

Diastolic Dysfunction1 trial

Tadalafil Effects in Left Ventricle Diastolic Dysfunction in Resistant Hypertensive Patients

Completed·UUniversity of Campinas, Brazil·N/A·NCT01743911·20 enrolled

Metastatic Head and Neck Cancer1 trial

Tadalafil and Pembrolizumab in Recurrent or Metastatic Head and Neck Cancer

Completed·UUniversity of California, San Diego·Phase 2·NCT03993353·7 enrolled

Sickle Cell Disease1 trial

A Trial for Prevention of Recurrent Ischemic Priapism in Men With Sickle Cell Disease: A Pilot Study

Completed·VVanderbilt University Medical Center·Phase 2·NCT05142254·64 enrolled

Priapism1 trial

Tadalafil for Treatment of Priapism in Men With Sickle Cell Anemia

Withdrawn·JJohns Hopkins University·Phase 2·NCT00538564

Hepatocellular Carcinoma1 trial

Nivolumab (Anti-PD1), Tadalafil and Oral Vancomycin in People With Refractory Primary Hepatocellular Carcinoma or Liver Dominant Metastatic Cancer From Colorectal or Pancreatic Cancers

Terminated·NNational Cancer Institute (NCI)·Phase 2·NCT03785210·22 enrolled

Endothelial Function1 trial

Hookah Smoking, Carbon Monoxide, and Coronary Endothelial Function

Terminated·—·Phase 1·NCT03166787·60 enrolled

Age1 trial

Management of Prostatodynia in Younger Patients With Non-ablative Erbium:YAG Intraurethral Laser

Completed·AAdrian Gaspar·N/A·NCT04446598·36 enrolled

Spinal Cord Injury1 trial

Effect of Tadalafil (Cialis) on the Cardiovascular System of Spinal Cord Injury (SCI) Males

Completed·UUniversity of Manitoba·Phase 4·NCT01067391·20 enrolled

Prevention1 trial

The Efficacy of Tamsulosin and Tadalafil Compared to Placebo in the Treatment and Prevention of Urinary Disorders After Transperineal Prostate Biopsy

Unknown status·UUniversity Hospital of Split·Phase 4·NCT05537272·120 enrolled

Alzheimer's Disease1 trial

PDE5 Inhibitor for Alzheimer's Disease

Not yet recruiting·IImperial College London·Phase 2·NCT07172815·244 enrolled

Quality of Life1 trial

Tadalafil Taken Daily Compared to Placebo on Improvement of Getting and Maintaining an Erection and Sexual Quality of Life

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00422734·342 enrolled

Apathy1 trial

REmodelling in Diabetic CardiOmapathy: Gender Response to PDE5i InhibiTOrs

Completed·UUniversity of Roma La Sapienza·Phase 4·NCT01803828·120 enrolled

Insulin resistance1 trial

Effects on Insulin Resistance With Tadalafil in Type 2 Diabetes - a Double-blind, Placebo-controlled Crossover Study

Completed·GGöteborg University·Phase 2·NCT02601989·23 enrolled

ILD1 trial

Studying the Preference of Tadalafil to Sildenafil in Men With Problems Getting an Erection Across Nations

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00547287·2,760 enrolled

Monotherapy1 trial

A 48-week Study of the Effect of Dual Therapy (Inhaled Treprostinil and Tadafafil) Versus Monotherapy (Tadalafil).

Completed·SStanford University·Phase 4·NCT01305252·21 enrolled

Interstitial Lung Disease1 trial

A Trial of Tadalafil in Interstitial Lung Disease of Scleroderma

Completed·SSanjay Gandhi Postgraduate Institute of Medical Sciences·Phase 3·NCT01553981·40 enrolled

Hyperplasia1 trial

Safety and Efficacy of Tadalafil vs. Tadalafil With Sildosin in the Management of Moderately and Severely Symptomatic Patients of Prostatic Hyperplasia

Unknown status·MMenoufia University··NCT04577040·400 enrolled

Peripheral Neuropathy1 trial

o Tadalafil for Prevention of Docetaxel-Induced Peripheral Neuropathy in Prostate Cancer

Completed·TTri-Service General Hospital·Phase 2·NCT07333976·90 enrolled

Sexual Dysfunction1 trial

Efficiency of Tadalafil for Management of Female Sexual Dysfunction

Unknown status·KKasr El Aini Hospital·Phase 2/3·NCT05266651·24 enrolled

Female1 trial

Management of OAB in Female Patients .

Completed·EElsayed Abdelhalim Elsayed·N/A·NCT06184334·300 enrolled

Resistance1 trial

Use of a Phosphodiesterase Type 5 Inhibitor to Improve Anabolic Resistance in Older Adults

Withdrawn·UUniversity of Arkansas··NCT05458232

Diabetic Nephropathy1 trial

Investigational and Comparative Study in the Management of Diabetic Nephropathy

Completed·TTanta University·Phase 3·NCT05487755·90 enrolled

Cerebral Small Vessel Disease1 trial

Improving Cerebral Blood Flow and Cognition in Patients with Cerebral Small Vessel Disease. the ETLAS-2 Trial

Active, not recruiting·CChristina Kruuse·Phase 2·NCT05173896·100 enrolled

Safety and Efficacy1 trial

Safety and Efficacy Evaluation of BZ371A Topically Applied on Prostatectomized Patients

Recruiting·BBiozeus Biopharmaceutical S.A.·Phase 2·NCT05558007·72 enrolled

Systemic1 trial

Effect of Phosphodiesterase-5 Inhibition With Tadalafil on SystEmic Right VEntricular Size and Function

Completed·IInsel Gruppe AG, University Hospital Bern·Phase 3·NCT03049540·100 enrolled

Double J Stent1 trial

Double j Stent Related Symptoms

Completed·KKafrelsheikh University·Phase 1·NCT07447518·535 enrolled

Insulin Secretion1 trial

Effect of Tadalafil on Insulin Secretion and Insulin Sensitivity in Obese Men.

Completed·UUniversity of Guadalajara·Phase 4·NCT02595684·18 enrolled

Surgery1 trial

Tadalafil in Treating Patients Undergoing Surgery for Cancer of the Oral Cavity or Oropharynx

Completed·—·N/A·NCT00843635·35 enrolled

Erectile Dysfunction Following Radical Prostatectomy1 trial

Multimodal Perioperative Optimisation for Patients Undergoing Robot-Assisted Radical Prostatectomy: A Randomised Controlled Trial Targeting Postoperative Erectile Dysfunction (ROBOPREP Trial)

Recruiting·SSurgical Outcomes Research Centre (SOuRCe)·Phase 2·NCT07576335·64 enrolled

PreDiabetes1 trial

The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics

Recruiting·PPhilip Kern·Approved·NCT05051436·96 enrolled

Diabetic Foot1 trial

A Case Study of a Patient With a Diabetic Foot Ulcer (DFU) With Management by Ultrasonic Enhancement Delivery of Phosphodiesterase Inhibitors Nanoparticles

Completed·DDeraya University·Preclinical·NCT07690566·1 enrolled

Fontan1 trial

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy of Tadalafil Versus Placebo in Improving Hemodynamics and End-Organ Dysfunction in Fontan Physiology (TRIUMPH Trial)

Recruiting·MMayo Clinic·Phase 3·NCT05206955·42 enrolled

Gastric Adenocarcinoma1 trial

An Open-Label, Phase II Single-Arm, Window Trial of Tadalafil Effect + Chemotherapy in Patients With Resectable Gastric/GEJ Adenocarcinoma

Active, not recruiting·UUniversity of Arizona·Phase 2·NCT05709574·11 enrolled

Unspecified11 trials

To Determine Effect and Safety of Tadalafil Taken by Men of Different Races and With Different Diseases When Needed for Erections

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00547417·1,933 enrolled

To Determine How Different Doses of Tadalafil Work on Getting and Keeping an Erection 26 or 36 Hours After Taking

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00547508·485 enrolled

Pharmacokinetic of Tadalafil Co-administered With Tipranavir/Ritonavir to Healthy Male Volunteers

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02253862·17 enrolled

Show 8 more trials

Silodosin, Tadalafil Alone vs. Silodosin Plus Tadalafil as MET for Lower Ureteric Stones

Completed·—·N/A·NCT05789732·168 enrolled

A Bioavailability Study of LY2452473 and Tadalafil

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT01401543·24 enrolled

Daily Tadalafil on Body Fat and Lean Mass

Completed·UUniversity of Roma La Sapienza·Phase 4·NCT02554045·20 enrolled

Study of Retinal and Choriocapillary Vascular Changes in Patients Undergoing Tadalafil 20mg for More Than 6 Months

Completed·FFederico II University··NCT04491773·54 enrolled

Study of Retinal and Choriocapillary Vascular Changes in Patients Undergoing Tadalafil 20mg

Completed·FFederico II University··NCT04164355·40 enrolled

Tadalafil Daily Used Post Turp

Completed·KKafrelsheikh University··NCT06788704·270 enrolled

Effects of Tadalafil on LMR and MHR in Patients With ED

Completed·SSamsun Liv Hospital··NCT03918993·62 enrolled

Tadalafil Plus Tamsulosin for Male LUTS and ED

Completed·UUniversity of Florence··NCT04383093·75 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 7, 2008

CIALIS

NDA NDA021368

May 22, 2009

ADCIRCA

NDA NDA022332

Jun 17, 2022

TADLIQ

NDA NDA214522

Jun 28, 2024

CHEWTADZY

NDA NDA218527

Sources

References

[1]
ClinicalTrials.gov — 198 trial records for Tadalafil. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Cialis drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Tadalafil compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Tadalafil. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA218527). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Cialis. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Eli Lilly company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Phosphodiesterase 5a Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Eli Lilly

Patent Landscape[6]

Patent Cliff

Dec 23, 2038

Earliest patent expiration — generic entry possible after this date

Patent #Expires

12691120Dec 23, 2038

12697338Dec 23, 2038

12721849Dec 24, 2038

12708626Dec 24, 2038

11382917Dec 24, 2038

3 more patents

12186322Dec 24, 2038

11975006Dec 24, 2038

11666576Dec 24, 2038