Last update 16 May 2024

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
(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, Tadalafil (JAN/USP/INN)
+ [29]
Target
Mechanism
PDE5A inhibitors(Phosphodiesterase 5A inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
EU (12 Nov 2002),
RegulationOrphan Drug (US), Priority Review (CN)
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Structure

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
US
06 Oct 2011
Familial Primary Pulmonary Hypertension
NO
01 Oct 2008
Familial Primary Pulmonary Hypertension
IS
01 Oct 2008
Familial Primary Pulmonary Hypertension
EU
01 Oct 2008
Familial Primary Pulmonary Hypertension
LI
01 Oct 2008
Pulmonary Arterial Hypertension
NO
01 Oct 2008
Pulmonary Arterial Hypertension
LI
01 Oct 2008
Pulmonary Arterial Hypertension
IS
01 Oct 2008
Pulmonary Arterial Hypertension
EU
01 Oct 2008
Erectile Dysfunction
IS
12 Nov 2002
Erectile Dysfunction
EU
12 Nov 2002
Erectile Dysfunction
NO
12 Nov 2002
Erectile Dysfunction
LI
12 Nov 2002
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Prostatic HyperplasiaPhase 2
DE
31 Jan 2009
Erectile DysfunctionPhase 2
DE
01 Aug 2008
Erectile DysfunctionPhase 2
AU
01 Aug 2008
Spinal Cord InjuriesPhase 1
US
01 Sep 2004
Prostatic HyperplasiaDiscovery
AR
31 Jan 2009
Erectile DysfunctionDiscovery
BR
01 Aug 2008
Erectile DysfunctionDiscovery
IT
01 Aug 2008
Erectile DysfunctionDiscovery
ES
01 Aug 2008
Erectile DysfunctionDiscovery
GB
01 Aug 2008
Erectile DysfunctionDiscovery
MX
01 Aug 2008
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
55
yrxfhubyeb(kpyqtgmecz) = increased non-significantly in all subcortical areas bybgmmeeuv (oetcbvisqz )
Negative
04 Aug 2022
Placebo
Phase 4
46
(ndznfzcaxg) = xbfozijqdh ostdikjuet (qosmalgpce )
Positive
21 Oct 2019
Phase 4
24
bqmcuprhbw(kdlzusztzb) = kbngwuaake iogfcowuis (plsfoxqvve, 4.0 - 12.9)
Positive
01 Nov 2015
Phase 3
695
-
Positive
01 Jan 2015
Placebo+finasteride
Phase 3
-
(ackkobuedj) = rnzismgoye elmswdewrl (lbujtxizvi )
Negative
29 Aug 2020
(ackkobuedj) = fwynvrnnar elmswdewrl (lbujtxizvi )
Phase 2/3
12
(uxkousnswy) = no overall improvement dslozyxjlv (npubzfmsjy )
Negative
01 Dec 2016
NEWS
ManualManual
Not Applicable
635
他达拉非5mg每日一次
(mcnugukwcq) = bgoyvhgaxy uklmliwlzq (xhlivlhyrc )
Positive
13 Mar 2024
Phase 3
325
(xgvtpieymm) = yogepiunsq mgftpjfudh (dvwfuvnamn )
Positive
01 Nov 2011
Placebo
(xgvtpieymm) = mmlvlwzwdm mgftpjfudh (dvwfuvnamn )
Phase 1
46
(arejxgcyxl) = addfxlexnc qqpsghqgaw (jyhcbuidax )
Positive
15 Dec 2021
Phase 3
35
(flusvvcrgf) = qhotarfqiy lsvapkqtqc (iyxpxqtxoa, 20.41)
Positive
23 Jun 2021
Placebo
(flusvvcrgf) = lyyeaizbww lsvapkqtqc (iyxpxqtxoa, 20.78)
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Regulation

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