TheraRadar
Data updated: May 26, 2026

TADALAFIL

Phosphodiesterase 5 Inhibitors
Urology Approved 2018-05-22

Tadalafil treats erectile dysfunction and helps patients with the signs and symptoms of benign prostatic hyperplasia (BPH). It is also used for men who experience both conditions at the same time. When used in combination with finasteride to begin BPH therapy, the medication is recommended for up to 26 weeks.

Source: FDA Label • NORVIUM BIOSCIENCE • Phosphodiesterase 5 Inhibitor
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How TADALAFIL Works

Tadalafil works by inhibiting the phosphodiesterase type 5 (PDE5) enzyme, which leads to increased levels of cyclic GMP in smooth muscle cells. This increase in cyclic GMP promotes smooth muscle relaxation and blood flow in the penis during sexual stimulation, and it also affects the smooth muscle of the prostate and bladder.

Source: FDA Label
18
Indications
--
Phase 3 Trials
8
Years on Market

Details

Status
Discontinued
First Approved
2018-05-22
Routes
ORAL
Dosage Forms
TABLET

Companies

NORVIUM BIOSCIENCE MACLEODS PHARMS LTD SUNSHINE WATSON LABS INC Aurobindo Pharma ACCORD HLTHCARE UNICHEM Cipla QILU PHARM HAINAN UMEDICA HANGZHOU BINJIANG Dr. Reddy's PRINSTON INC Teva NOVITIUM PHARMA HETERO LABS LTD III CHARTWELL RX VKT PHARMA SHANDONG ALEMBIC AJANTA PHARMA LTD PHARMOBEDIENT FOURRTS LABS RISING Sun Pharma ZYDUS PHARMS AMNEAL PHARMS CO Lupin TORRENT
Active Ingredient: TADALAFIL

TADALAFIL Approval History

2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
178 FDA actions from 2018 to 2025
Feb 2025 SUPPL
Label · Labeling
Dec 2024 SUPPL
Mfg · Manufacturing (CMC)
Aug 2024 SUPPL
Label · Labeling

What TADALAFIL Treats

2 indications

TADALAFIL is approved for 2 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Erectile Dysfunction
  • Benign Prostatic Hyperplasia
Source: FDA Label

TADALAFIL Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Direct competitors

5

Same target(s) AND same indication — head-to-head.

VYBRIQUE
IBSA
2025 1 indic.
AVANAFIL
HETERO LABS
2024 1 indic.

MoA expansion candidates

1

Same target(s), different indications — where else is this mechanism being explored?

OPSYNVI
ACTELION
2024 1 indic.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

GEMTESA
SUMITOMO PHARMA
2020 2 indic.
SILODOSIN
ZYDUS PHARMS
2017 1 indic.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to TADALAFIL

3 of 19

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

CIALIS
TADALAFIL
2 shared
Eli Lilly
Shared indications:
Erectile DysfunctionBenign Prostatic Hyperplasia
ALFUZOSIN HYDROCHLORIDE
ALFUZOSIN HYDROCHLORIDE
1 shared
Apotex
Shared indications:
Benign prostatic hyperplasia
AVANAFIL
AVANAFIL
1 shared
HETERO LABS LTD V
Shared indications:
Erectile Dysfunction
View all 19 similar drugs Pro
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Clinical Trial Registry

85 trials
Trial Sponsor ID Phase Status Title
NCT07245680 COMMODITIES APHP230847 2023-509891-40-00 Ph 3 recruiting COMMODITIES Trial: Initial Dual Oral Therapy vs Monotherapy in PAH With Cardiovascular Comorbidities
NCT05937854 BETTER COPD-PH PULM-002-22F I01CX002543 Ph 2 recruiting Breathe Easier With Tadalafil Therapy for Dyspnea in COPD-PH
NCT05014776 results posted J2180 IRB00291762, 5P01CA247886 Ph 2 completed Study of CRS-207, Pembrolizumab, Ipilimumab, and Tadalafil in Metastatic Pancreatic Cancer
NCT03785210 results posted 190033 19-C-0033 Ph 2 terminated Nivolumab (Anti-PD1), Tadalafil and Oral Vancomycin in People With Refractory Primary Hepatocellular Carcinoma or Liver Dominant Metastatic Cancer From Colorectal or Pancreatic Cancers
NCT03993353 results posted 190098 Ph 2 completed Tadalafil and Pembrolizumab in Recurrent or Metastatic Head and Neck Cancer
NCT05844462 ERASE PH-COPD APHP211052 Ph 3 recruiting Tadalafil for Severe Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease
NCT05206955 21-009890 R01HL160761-01 Ph 3 recruiting Study of Tadalafil vs. Placebo for Improving Hemodynamics and End-Organ Dysfunction in Fontan Physiology
NCT07172815 174242 Ph 2 not yet recruiting PDE5 Inhibitor for Alzheimer's Disease
NCT06290713 IRB202301491 1R21AR079755-01, PRO00050023 Ph 2 recruiting Vasodilator and Exercise Study for DMD (VASO-REx)
NCT04235270 CR108735 67896062PAH1006 Ph 1 completed A Study of Macitentan and Tadalafil as a Fixed Dose Combination and the Free Combination in Healthy Adult Participants
NCT02558231 TRITON results posted AC-065A308 Ph 3 completed The Efficacy and Safety of Initial Triple Versus Initial Dual Oral Combination Therapy in Patients With Newly Diagnosed Pulmonary Arterial Hypertension
NCT05195775 IRB202102391 OCR41391 Ph 2, Ph 3 active not recruiting Tadalafil as Adjuvant Therapy for DMD
NCT04483115 TPN171H-P201 Ph 2 completed Acute Haemodynamic Study of TPN171H in Patients with Pulmonary Arterial Hypertension
NCT05142254 PIN 202504 Ph 2 completed A Trial for Prevention of Recurrent Ischemic Priapism in Men With Sickle Cell Disease: A Pilot Study
NCT06466369 461 Ph 3 completed Administration of Tadalafil in Patients With Benign Prostatic Hyperplasia
NCT04947631 DKF-313-P3 Ph 3 completed Efficacy and Safety of DKF-313 in Patients With Benign Prostatic Hyperplasia
NCT04757662 202103257 Ph 1 completed Tadalafil to Overcome Immunosuppression During Chemoradiotherapy for IDH-wildtype Grade III-IV Astrocytoma
NCT02611258 ERGO ERGO 2015-004497-15 Ph 2 completed Endocrine Cardiomyopathy in Cushing Syndrome: Response to Cyclic GMP PDE5 inhibitOrs
NCT02611336 SUM SUM 2015-004498-34 Ph 2 completed Endocrine Cardiomyopathy: Response to Cyclic GMP PDE5 Inhibitors in Acromegaly Cardiomyopathy
NCT05818670 tadalafil vs tamsulosin in bph Ph 4 completed Comparison Between Tamsulosin and Tadalafil in Management of Benign Prostatic Hyperplasia Long Term Study
NCT05052879 EMS0220 - TORONTO Ph 3 not yet recruiting Efficacy and Safety of Toronto Association in the Treatment of Erectile Dysfunction and Premature Ejaculation
NCT02450253 PASTIS 14.0189 2015-001235-20, 15/LO/0714 Ph 2 completed Perfusion by Arterial Spin Labelling Following Single Dose Tadalafil in Small Vessel Disease (PASTIS) Trial
NCT04069936 CLN-P18001 Ph 2 terminated 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
NCT02819440 results posted 160208 Ph 2 completed PDE5 Inhibition for Obesity-Related Cardiometabolic Dysfunction
NCT01824290 results posted 10609 H6D-MC-LVHV, 2012-002354-23 Ph 3 completed A Study of Tadalafil in Pediatric Participants With Pulmonary Arterial Hypertension (PAH)
NCT02544880 20140960 Ph 1 completed PDE5 Inhibition Via Tadalafil to Enhance Anti-Tumor Mucin 1 (MUC1) Vaccine Efficacy in Patients With HNSCC
NCT01970176 Aim2 results posted 11-004644 HL76611-07P3 Ph 1, Ph 2 completed Study to Determine How Cialis Effects the Renal Function in Response to Volume Expansion in Preclinical Systolic Cardiomyopathy (Aim2)
NCT02252367 ANDRO-AOUC-2014-01 Ph 4 completed Effect of 12 Weeks Treatment With Tadalafil vs Placebo on Lower Urinary Tract Symptoms
NCT03166787 Protocol 47441 R21DA041596 Ph 1 terminated Hookah Smoking, Carbon Monoxide, and Coronary Endothelial Function
NCT01862536 TADA-PHILD results posted CLIN-008-12F Ph 2 completed Tadalafil for Pulmonary Hypertension Due to Chronic Lung Disease
NCT02891850 REPLACE results posted 18588 2016-001067-36 Ph 4 completed Riociguat rEplacing PDE-5i Therapy evaLuated Against Continued PDE-5i thErapy
NCT02058095 Aim 3 results posted 11-006194 HL76611-07P3 Ph 1, Ph 2 completed Study to Determine How Cialis Effects the Renal Function in Response to Volume Expansion in Preclinical Diastolic Cardiomyopathy (Aim3)
NCT02595684 results posted TADALAFIL-OB Ph 4 completed Effect of Tadalafil on Insulin Secretion and Insulin Sensitivity in Obese Men.
NCT02300259 results posted 15523 I7T-MC-RMAG Ph 1 completed A Study of LY2623091 in Healthy Participants
NCT02194465 results posted 15525 I7T-MC-RMAH Ph 2 completed A Study of LY2623091 in Participants With High Blood Pressure
NCT01697800 results posted J1247 2P50DE019032, NA_00073880 Ph 2 completed A Phase II Trial of Tadalafil in Patients With Squamous Cell Carcinoma of the Upper Aero Digestive Tract
NCT01238224 2007-003921-25 Ph 1 terminated Effects of PDE-5 Inhibition on Postprandial Hyperglycemia in Type 2 Diabetes
NCT02601989 MAKROTAD 2015-09-14 2015-000573-12 Ph 2 completed Effects on Insulin Resistance With Tadalafil in Type 2 Diabetes - a Double-blind, Placebo-controlled Crossover Study
NCT01865084 results posted 15122 H6D-MC-LVJJ Ph 3 terminated A Study of Tadalafil for Duchenne Muscular Dystrophy
NCT02968901 OPTIMA AC-055-405 Ph 4 terminated Clinical Study Evaluating the Effects of First-line Oral cOmbination theraPy of maciTentan and tadalafIl in Patients With Newly Diagnosed pulMonary Arterial Hypertension (OPTIMA)
NCT02224846 results posted 15382 H6D-GH-B022 Ph 4 completed A Study of Tadalafil (LY450190) in Chinese Men With Erectile Dysfunction
NCT01803828 RECOGITO RECOGITO Ph 4 completed REmodelling in Diabetic CardiOmapathy: Gender Response to PDE5i InhibiTOrs
NCT01401543 results posted 13326 I4K-MC-GPEA Ph 1 completed A Bioavailability Study of LY2452473 and Tadalafil
NCT01275339 ASPEN results posted 10-1334b Ph 4 terminated Aortic Stenosis and PhosphodiEsterase Type 5 iNhibition (ASPEN): A Pilot Study
NCT01160289 results posted 11888 I4K-MC-GPEC Ph 2 completed A Study of LY900010 in Erectile Dysfunction
NCT01374217 results posted J1167 NA_00049238 Ph 2 terminated Administration of Tadalafil in Conjunction With Lenalidomide and Dexamethasone in Patients With Multiple Myeloma
NCT01272388 ASPEN-AVR results posted 10-1334a Ph 4 terminated Aortic Stenosis and PhosphodiEsterase iNhibition With Aortic Valve Replacement (ASPEN-AVR): A Pilot Study
NCT01544998 results posted 11-004257 UL1RR024150, 5P01HL076611 Ph 1, Ph 2 completed Tadalafil and Nesiritide as Therapy in Pre-clinical Heart Failure
NCT00931528 results posted RTOG 0831 CDR0000647146, NCI-2011-01934 Ph 3 completed Tadalafil in Preventing Erectile Dysfunction in Patients With Prostate Cancer Treated With Radiation Therapy
NCT01903083 CRIT 13-026A Ph 1 completed Chemoimmunotherapy and Radiation in Pancreatic Cancer

Showing 50 of 85 trials

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Completed studies with published results, ranked by significance

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Trial Timeline

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Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

TADALAFIL FDA Label Details

Indications & Usage

TADALAFIL is indicated for the treatment of Erectile Dysfunction; Benign Prostatic Hyperplasia.

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Data Sources

FDA Approval: ANDA206957 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.