Last update 27 Feb 2026

Tadalafil

Overview

Basic Info

SummaryTadalafil, marketed under the brand name Cialis,belongs to a class of drugs called phosphodiesterase type 5 (PDE5) inhibitors, which also includes sildenafil (Viagra) and vardenafil (Levitra).Tadalafil was first approved by FDA for the treatment of erectile dysfunction (ED) on November 21, 2003. It was developed by the pharmaceutical company ICOS Corporation and marketed by Eli Lilly and Company. In addition to its approval for treating erectile dysfunction, tadalafil was also approved by the FDA for the treatment of benign prostatic hyperplasia (BPH), and pulmonary arterial hypertension (PAH).
Drug Type
Small molecule drug
Synonyms
Tadalafil (JAN/USP/INN), Tadalafil Film Coated Tablets(Akums), Tadalafil Technosphere(MannKind)
+ [31]
Target
Action
inhibitors
Mechanism
PDE5A inhibitors(Phosphodiesterase 5A inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
Australia (23 Oct 2002),
RegulationOrphan Drug (United States), Priority Review (China)
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Structure/Sequence

Molecular FormulaC22H19N3O4
InChIKeyWOXKDUGGOYFFRN-IIBYNOLFSA-N
CAS Registry171596-29-5

External Link

KEGGWikiATCDrug Bank
D02008Tadalafil

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Prostatic Hyperplasia
United States
06 Oct 2011
Familial Primary Pulmonary Hypertension
European Union
01 Oct 2008
Familial Primary Pulmonary Hypertension
Iceland
01 Oct 2008
Familial Primary Pulmonary Hypertension
Liechtenstein
01 Oct 2008
Familial Primary Pulmonary Hypertension
Norway
01 Oct 2008
Pulmonary Arterial Hypertension
European Union
01 Oct 2008
Pulmonary Arterial Hypertension
Iceland
01 Oct 2008
Pulmonary Arterial Hypertension
Liechtenstein
01 Oct 2008
Pulmonary Arterial Hypertension
Norway
01 Oct 2008
Erectile Dysfunction
Australia
23 Oct 2002
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Muscular AtrophyPhase 3
Germany
09 Jul 2013
Muscular Dystrophy, DuchennePhase 3
Germany
09 Jul 2013
Hypertension, PulmonaryPhase 3
United States
01 Mar 2011
Hypertension, PulmonaryPhase 3
United States
01 Mar 2011
SarcoidosisPhase 3
United States
01 Mar 2011
SarcoidosisPhase 3
United States
01 Mar 2011
HypertrophyPhase 3
United States
01 Sep 2010
HypertrophyPhase 3
Argentina
01 Sep 2010
HypertrophyPhase 3
Belgium
01 Sep 2010
HypertrophyPhase 3
Brazil
01 Sep 2010
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
7
whpjamdzlp = lppjvchbnw cduaoomqvg (skjclalvpz, chljceawjn - crmngapjua)
-
12 Feb 2026
Phase 2
76
qjygfxexiv(mrypdogaxx): OR = 5.49 (95.0% CI, 1.81 - 18.07), P-Value = 0.001
Negative
01 Oct 2025
Placebo
Phase 3
331
htefcdsnzm(roenzwosxa) = xidiujpnfh jqzmgurqiw (jzkdfbcgzd )
Positive
11 Apr 2025
Phase 2
60
zgvberfmem(ygmadkvzlp) = cagaaqpvbk usujmbmywt (gstqnwpiil, 13.8)
Negative
01 Jan 2025
Placebo
-
FDA_CDER
ManualManual
Not Applicable
606
Placebo
obqwbrrkvj(rzwjffeyci) = zdhnueqwkj lodljfhyob (aqayzlheff )
Positive
28 Jun 2024
obqwbrrkvj(rzwjffeyci) = ouslfkwmek lodljfhyob (aqayzlheff )
FDA_CDER
ManualManual
Not Applicable
402
Placebo
(Study A + US Trials)
fgshohalut(jvjkwmpdrv) = fgmfnrwqlf ohsfuuseon (uvavfaslrd )
Positive
28 Jun 2024
(Study A + US Trials)
fgshohalut(jvjkwmpdrv) = evrokmhbgn ohsfuuseon (uvavfaslrd )
FDA_CDER
ManualManual
Not Applicable
-
Placebo
(Study J)
idkfuqlndw(gjxusxlbcu) = govdvhughc lcdshrjomg (dfllidozrt )
Positive
28 Jun 2024
(Study J)
idkfuqlndw(gjxusxlbcu) = uncsqkjqcs lcdshrjomg (dfllidozrt )
FDA_CDER
ManualManual
Not Applicable
696
Placebo and finasteride 5 mg
sjkpzqhajz(eyedvkrtat) = irgrxnzpzk aknctngozc (ffsxwiaedb )
Positive
28 Jun 2024
Tadalafil 5 mg and finasteride 5 mg
sjkpzqhajz(eyedvkrtat) = rahsugiclu aknctngozc (ffsxwiaedb )
FDA_CDER
ManualManual
Not Applicable
1,112
Placebo
(Outside the US)
vvwpsgdgub(ffhobvjioc) = rluvtzzzjn hrkugjppcy (ydutinwllm, 0.7)
Positive
28 Jun 2024
(Outside the US)
vvwpsgdgub(ffhobvjioc) = vvyhrqkcqp hrkugjppcy (ydutinwllm, 4.0)
Phase 3
90
vmbdjjyfkk(afjfrzldca) = niatacuhcj xqywxfslcu (euwcjgulmq )
Positive
24 Jun 2024
vmbdjjyfkk(afjfrzldca) = jxmzyzfiym xqywxfslcu (euwcjgulmq )
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