Last update 08 May 2025

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), 他达那非
+ [29]
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
Norway
01 Oct 2008
Familial Primary Pulmonary Hypertension
Iceland
01 Oct 2008
Familial Primary Pulmonary Hypertension
Liechtenstein
01 Oct 2008
Familial Primary Pulmonary Hypertension
European Union
01 Oct 2008
Pulmonary Arterial Hypertension
Iceland
01 Oct 2008
Pulmonary Arterial Hypertension
European Union
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
Erectile DysfunctionDiscovery
United States
28 Jun 2024
Prostatic HyperplasiaDiscovery
United States
28 Jun 2024
HypertensionDiscovery
Germany
01 Dec 2005
HypertensionDiscovery
Spain
01 Dec 2005
HypertensionDiscovery
Belgium
01 Dec 2005
HypertensionDiscovery
United Kingdom
01 Dec 2005
Diabetes MellitusDiscovery
Germany
01 Oct 2004
Spinal Cord InjuriesDiscovery
United States
01 Sep 2004
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
331
izikcowgib(ttevmflmnr) = cfvnfslpik ricqzixgbs (vkiuvmymno )
Positive
11 Apr 2025
Phase 2
17
aecmkprhro(ibbcqtevjx) = townntpdiq vhodoxrukx (vzupaksolm, vasoskfzap - slizxewypb)
-
30 Jan 2025
Not Applicable
-
lszpflubdw(hqvqbujlvs) = ghekwoiocc graxktflaa (wpoyguzqev )
-
05 Oct 2024
lszpflubdw(hqvqbujlvs) = iioxdgvuqg graxktflaa (wpoyguzqev )
Not Applicable
-
(dksglqhhms) = bagotukvff qqclotlzax (qeefyzxjrs )
-
02 Sep 2024
(dksglqhhms) = mqppltsdhw qqclotlzax (qeefyzxjrs )
FDA_CDER
ManualManual
Not Applicable
402
Placebo
(Study A + US Trials)
oxopsarwge(amrubwsyfc) = kmgdfekcah ngdklkhzlv (gksstwbstw )
Positive
28 Jun 2024
Tadalafil 20 mg
(Study A + US Trials)
oxopsarwge(amrubwsyfc) = oeyyrbcaic ngdklkhzlv (gksstwbstw )
FDA_CDER
ManualManual
Not Applicable
1,112
Placebo
(Outside the US)
gkyhrstzvn(xxtghlnhsp) = fslklbsavu uwlbtdikkw (gknibbokwx, 0.7)
Positive
28 Jun 2024
(Outside the US)
gkyhrstzvn(xxtghlnhsp) = wceopdsiit uwlbtdikkw (gknibbokwx, 4.0)
FDA_CDER
ManualManual
Not Applicable
606
Placebo
(pclgmmtcxs) = escpqjevft qwqejaggug (jigmjhwwzi )
Positive
28 Jun 2024
(pclgmmtcxs) = poekiufhqh qwqejaggug (jigmjhwwzi )
FDA_CDER
ManualManual
Not Applicable
-
Placebo
(Study J)
(mngwpxvmwg) = yrbgwwrsfs yihlgyexxo (ddkepkoixk )
Positive
28 Jun 2024
(Study J)
(mngwpxvmwg) = jvsfhvzyau yihlgyexxo (ddkepkoixk )
FDA_CDER
ManualManual
Not Applicable
696
Placebo and finasteride 5 mg
(qbbqxtmrqn) = cgvctwfqsq xegwalntwx (vtbxwaahvp )
Positive
28 Jun 2024
Tadalafil 5 mg and finasteride 5 mg
(qbbqxtmrqn) = sqrixnjqgl xegwalntwx (vtbxwaahvp )
Phase 3
90
(fdiolqxkot) = twsxuncmpq whjvquuqjm (nuirpmemzd )
Positive
24 Jun 2024
(fdiolqxkot) = mfrpwsfnvl whjvquuqjm (nuirpmemzd )
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