Data updated: May 26, 2026
CIALIS (tadalafil)
Phosphodiesterase 5 Inhibitors
Trial Activity: Declining
Urology
Approved 2003-11-21
CIALIS is indicated for the treatment of Erectile Dysfunction; Benign Prostatic Hyperplasia.
How CIALIS Works
Tadalafil inhibits the phosphodiesterase type 5 (PDE5) enzyme, preventing the degradation of cyclic guanosine monophosphate (cGMP). During sexual stimulation, nitric oxide is released, stimulating cGMP production; by inhibiting PDE5, tadalafil increases cGMP levels, leading to smooth muscle relaxation and increased blood flow into the corpus cavernosum. While PDE5 is also present in the smooth muscle of the prostate and bladder, the exact mechanism by which its inhibition reduces BPH symptoms has not been fully established.
Development Insights
Ottawa Hospital Research Institute conducting 1 trials (33%)
4 indications explored (Focused)
→ abdominal cancer (1 trials)
→ benign prostate hyperplasia (1 trials)
→ healthy (1 trials)
5
Indications
--
Phase 3 Trials
1
Priority Reviews
22
Years on Market
Details
- Status
- Prescription
- First Approved
- 2003-11-21
- Routes
- ORAL
- Dosage Forms
- TABLET
CIALIS Approval History
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
88 FDA actions from 2003 to 2018 · 4 indication expansions
Jul 2016 SUPPL
Mfg · Manufacturing (CMC)
Sep 2015 SUPPL
Mfg
What CIALIS Treats
2 indicationsCIALIS is approved for 2 conditions since its original approval in 2003. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Erectile Dysfunction
- Benign Prostatic Hyperplasia
Source: FDA Label
CIALIS Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
5
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
1
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
10
Same indication, different mechanism — what else might this patient receive?
Unlock 11 more competitors across all three rings.
Upgrade to Pro 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 CIALIS
3 of 19FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
TADALAFIL
TADALAFIL
NORVIUM BIOSCIENCE
Shared indications:
Erectile DysfunctionBenign Prostatic Hyperplasia
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Clinical Trial Registry
88 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 |
| NCT02998736 PERIOP-04 | 20160855-01H | Ph 1 | completed | Trial of Perioperative Tadalafil and Influenza Vaccination in Cancer Patients Undergoing Major Surgical Resection of a Primary Abdominal Malignancy |
| 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) |
| NCT02352311 | DK-DT-002 | Ph 1 | completed | Safety and Pharmacokinetic Characteristics of DKF-313 |
| 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 |
Showing 50 of 88 trials
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Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
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.
CIALIS FDA Label Details
Indications & Usage
FDA Label (PDF)CIALIS is indicated for the treatment of Erectile Dysfunction; Benign Prostatic Hyperplasia.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment