TheraRadar
Data updated: May 26, 2026

CHEWTADZY (tadalafil)

Urology Approved 2024-06-28
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
1
Years on Market

Details

Status
Discontinued
First Approved
2024-06-28
Routes
ORAL
Dosage Forms
TABLET, CHEWABLE

Companies

B BETTER
Active Ingredient: TADALAFIL

CHEWTADZY Approval History

2025
2026
Original
New Indication
New Form
Label Update
3 FDA actions from 2024 to 2024
Jun 2024 ORIGINAL
New Form · Type 3 - New Dosage Form
FDA Letter Label

What CHEWTADZY Treats

1 FDA approvals

Originally approved for its first indication in 2024 .

  • Other (1)
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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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Active Pipeline

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

CHEWTADZY FDA Label Details

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Data Sources

FDA Approval: NDA218527 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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