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Drug

Tadalafil

Approved · FDA / EMA
Emerging researchLate-stage development
Also known as Adcirca, Alyq, Cialis, Entadfi+5 more

Adcirca, Alyq, Cialis, Entadfi, Opsynvi, Tadliq, Tadalafilo, (6R,12aR)-2,3,6,7,12,12a-Hexahydro-2-methyl-6-(3,4-(methylenedioxy)phenyl) pyrazino(1',2':1,6)pyrido(3,4-b)indole-1,4-dione, (6R-trans)-6-(1,3-Benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-pyrazino(1',2':1,6)pyrido(3,4-b)indole-1,4-dione.

RxNorm358263ChEMBLCHEMBL779UNII742SXX0ICT
3
Research papers
24
Active clinical trials
6
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics

Clinical trial2026-08-01Primary completion · ClinicalTrials.gov

Tamsulosin With Versus Without Tadalafil for Trial Without Catheter After Acute Urinary Retention Due to Benign Prostatic Hyperplasia: A Prospective Double-Blind Randomized Trial

Clinical trial2026-06-17Results expected Q4 2027 · ClinicalTrials.gov

L-Citrulline Versus Tadalafil Versus Combination Therapy in Mild to Moderate Erectile Dysfunction: A Prospective Randomized Trial

Clinical trial2026-06-12Results expected Q4 2026 · ClinicalTrials.gov

PLEASURE (Pleasing Lovers, Efficacy, Arousal, Satisfaction, and Uptake Research on Eroxon): A Pilot Randomized Trial of Eroxon® Gel as an Adjunct to Tadalafil in Young Men With Diabetes-Associated Erectile Dysfunction

Clinical trial2026-06-09Results expected Q3 2027 · ClinicalTrials.gov

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

Clinical trial2026-06-03Primary completion · ClinicalTrials.gov

Approval: TADALAFIL (ANDA217606)

Regulatory2024-08-13FDA

Approval: Tadalafil Lilly (EMA)

Regulatory2017-03-22EMA

Approval: Talmanco (previously Tadalafil Generics) (EMA)

Regulatory2017-01-09EMA

Tadalafil augments tumor specific immunity in patients with head and neck squamous cell carcinoma.

Research2015-01-01Clinical cancer research : an official journal of the American Association for Cancer Research

Approval: Tadalafil Mylan (EMA)

Regulatory2014-11-21EMA

Tadalafil reduces myeloid-derived suppressor cells and regulatory T cells and promotes tumor immunity in patients with head and neck squamous cell carcinoma.

Research2014-10-15Clinical cancer research : an official journal of the American Association for Cancer Research

Effects of once-daily tadalafil on treatment satisfaction, psychosocial outcomes, spontaneous erections, and measures of endothelial function in men with erectile dysfunction but naive to phosphodiesterase type 5 inhibitors.

Research2012-07-12Journal of andrology

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Tadalafil
Aliases & brands
AdcircaAlyqCialisEntadfiOpsynviTadliqTadalafilo(6R,12aR)-2,3,6,7,12,12a-Hexahydro-2-methyl-6-(3,4-(methylenedioxy)phenyl) pyrazino(1',2':1,6)pyrido(3,4-b)indole-1,4-dione(6R-trans)-6-(1,3-Benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-pyrazino(1',2':1,6)pyrido(3,4-b)indole-1,4-dione
RxNorm CUI
358263
ChEMBL ID
CHEMBL779
UNII
742SXX0ICT
Regulatory jurisdictions
fdaema

Regulatory timeline

6 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2002-11-12
Latest approval
2024-08-13
Authorities
FDA · EMA
Total events
6
fdaU.S. Food and Drug Administration· 1 event
2024-08-13Approval
Approval: TADALAFIL (ANDA217606)
Evidence ↗
emaEuropean Medicines Agency· 5 events
2017-03-22Approval
Approval: Tadalafil Lilly (EMA)
Indication: Treatment of erectile dysfunction in adult males.In order for tadalafil to be effective, sexual stimulation is required. Tadalafil Lilly is not indicated for use by women.… Show full indication

Treatment of erectile dysfunction in adult males.In order for tadalafil to be effective, sexual stimulation is required. Tadalafil Lilly is not indicated for use by women. Treatment of the signs and symptoms of benign prostatic hyperplasia in adult males.

Evidence ↗
2017-01-09Approval
Approval: Talmanco (previously Tadalafil Generics) (EMA)
Indication: Talmanco is indicated in adults for the treatment of pulmonary arterial hypertension (PAH) classified as WHO functional class II and III, to improve exercise capacity. Efficacy… Show full indication

Talmanco is indicated in adults for the treatment of pulmonary arterial hypertension (PAH) classified as WHO functional class II and III, to improve exercise capacity. Efficacy has been shown in idiopathic PAH (IPAH) and in PAH related to collagen vascular disease.

Evidence ↗
2014-11-21Approval
Approval: Tadalafil Mylan (EMA)

Indication: Treatment of erectile dysfunction in adult males. In order for tadalafil to be effective, sexual stimulation is required. Tadalafil Mylan is not indicated for use by women.

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

184 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
184
registered trials across all phases
LATEST COMPLETION 2026
24
Active studies
21
Recruiting
114
Late-stage (III+)
126
Completed
34
Discontinued
PHASE DISTRIBUTIONn = 184
Early Phase 13Phase 123Phase 1 / 25Phase 239Phase 2 / 36Phase 345Phase 445Phase N / A18

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Tamsulosin With Versus Without Tadalafil for Trial Without Catheter After Acute Urinary Retention Due to Benign Prostatic Hyperplasia: A Prospective Double-Blind Randomized Trial

RecruitingPH IVBeni-Suef Universityn=3202027

PLEASURE (Pleasing Lovers, Efficacy, Arousal, Satisfaction, and Uptake Research on Eroxon): A Pilot Randomized Trial of Eroxon® Gel as an Adjunct to Tadalafil in Young Men With Diabetes-Associated Erectile Dysfunction

Not yet recruitingPH IVUniversity of Miamin=302027

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

RecruitingPH IVMansoura Universityn=4802026

L-Citrulline Versus Tadalafil Versus Combination Therapy in Mild to Moderate Erectile Dysfunction: A Prospective Randomized Trial

RecruitingPH IVBeni-Suef Universityn=1332026

The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics

RecruitingPH IVPhilip Kernn=962026

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Randomized, Allocation-concealed, Assessor-blinded, Parallel-group Trial Evaluating the Association Between Erectile Dysfunction and Left Ventricular Diastolic Dysfunction and Comparing the Effects of Tadalafil, SGLT2 Inhibitors, and Their Combination in Patients With Metabolic Syndrome.

CompletedPH IVKafrelsheikh Universityn=602026

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

CompletedPH IVMenoufia Universityn=1852026

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

CompletedN/ADeraya Universityn=12025

Efficacy of Intracavernosal Injection of Platelet-Rich Plasma Alone Versus Combined With Oral Tadalafil in The Management of Erectile Dysfunction; A Prospective Randomized Study

CompletedPH IVBenha Universityn=1602025

Efficacy of Combination of Solifenacin and Tadalafil Versus Solifenacin Alone in Treatment of Overactive Bladder in Females

CompletedN/AAin Shams Universityn=802025

Effect of PDE5 Inhibition on Adipose Metabolism in Humans

CompletedPH IIVanderbilt University Medical Centern=892025

Research activity

3 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20122015
Journals, researchers & institutions
Top journals
  • Clinical cancer research : an official journal of the American Association for Cancer Research2
  • Journal of andrology1
Leading researchers
  • Borrello I2
  • Serafini P2
  • Weed DT2
  • Agrawal N1
  • Aversa A1
  • Basson BR1
  • Blanco R1
  • Brock GB1
Leading institutions
free-text, unnormalised
  • Greater Baltimore Medical Center1
  • Johns Hopkins Medical Institutions1
  • Johns Hopkins University1
  • Milton J Dance Head and Neck Center1
  • Milton J. Dance Head and Neck Center1
  • Sidney Kimmel Comprehensive Cancer Center1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.