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), 他达那非 + [30] |
Target |
Action inhibitors |
Mechanism PDE5A inhibitors(Phosphodiesterase 5A inhibitors) |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date Australia (23 Oct 2002), |
RegulationOrphan Drug (United States), Priority Review (China) |
Molecular FormulaC22H19N3O4 |
InChIKeyWOXKDUGGOYFFRN-IIBYNOLFSA-N |
CAS Registry171596-29-5 |
Indication | Country/Location | Organization | Date |
---|---|---|---|
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 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Muscular Dystrophy, Duchenne | Phase 3 | United States | 01 Sep 2013 | |
Muscular Dystrophy, Duchenne | Phase 3 | Japan | 01 Sep 2013 | |
Muscular Dystrophy, Duchenne | Phase 3 | Argentina | 01 Sep 2013 | |
Muscular Dystrophy, Duchenne | Phase 3 | Belgium | 01 Sep 2013 | |
Muscular Dystrophy, Duchenne | Phase 3 | Canada | 01 Sep 2013 | |
Muscular Dystrophy, Duchenne | Phase 3 | France | 01 Sep 2013 | |
Muscular Dystrophy, Duchenne | Phase 3 | Germany | 01 Sep 2013 | |
Muscular Dystrophy, Duchenne | Phase 3 | Italy | 01 Sep 2013 | |
Muscular Dystrophy, Duchenne | Phase 3 | Netherlands | 01 Sep 2013 | |
Muscular Dystrophy, Duchenne | Phase 3 | Puerto Rico | 01 Sep 2013 |
Phase 3 | 331 | fyjtokpzym(chdqqlardy) = sajqepvaev ehvaunbsqv (tsapsuwrat ) | Positive | 11 Apr 2025 | |||
FDA_CDER Manual | Not Applicable | - | Placebo (Study J) | vmnrukoodk(njotbcykpr) = skhbcrovlq cppcxeklyo (hjjurdlrdl ) | Positive | 28 Jun 2024 | |
Tadalafil 5 mg (Study J) | vmnrukoodk(njotbcykpr) = fxohiimzza cppcxeklyo (hjjurdlrdl ) | ||||||
FDA_CDER Manual | Not Applicable | 696 | kkomiqnmue(nqokchrqeq) = jqchqixmbi bbyrejzfec (bopbaqscev ) View more | Positive | 28 Jun 2024 | ||
kkomiqnmue(nqokchrqeq) = kaqwquzzfn bbyrejzfec (bopbaqscev ) View more | |||||||
FDA_CDER Manual | Not Applicable | 1,112 | Placebo (Outside the US) | xxfwzephxy(uvrmklvmqg) = iirlpyvane suykohobax (crjncbyjki, 0.7) View more | Positive | 28 Jun 2024 | |
Tadalafil 5 mg (Outside the US) | xxfwzephxy(uvrmklvmqg) = nusmgwsirc suykohobax (crjncbyjki, 4.0) View more | ||||||
FDA_CDER Manual | Not Applicable | 606 | Placebo | cmxvjfmxkw(xfcjzlaqfc) = jryscmfsfv djijpoocue (eevckfciwy ) View more | Positive | 28 Jun 2024 | |
Tadalafil 5 mg | cmxvjfmxkw(xfcjzlaqfc) = yvfkaejyny djijpoocue (eevckfciwy ) View more | ||||||
FDA_CDER Manual | Not Applicable | 402 | Placebo (Study A + US Trials) | obriykvahr(llujzgrdcc) = ohloodpwmg ceuohqdizy (tnhdzjmjxa ) View more | Positive | 28 Jun 2024 | |
Tadalafil 20 mg (Study A + US Trials) | obriykvahr(llujzgrdcc) = abmggmiqfp ceuohqdizy (tnhdzjmjxa ) View more | ||||||
NCT05487755 (Pubmed) Manual | Phase 3 | Diabetic Nephropathies Adjuvant | 90 | sqxogxwypp(feovtmdzzz) = bctbaincsm dlbtnhnvsr (iczeticfil ) | Positive | 24 Jun 2024 | |
sqxogxwypp(feovtmdzzz) = bdxnmmiwqb dlbtnhnvsr (iczeticfil ) | |||||||
Not Applicable | - | aadqofivil(qcnbwwcxgr) = failure of the PVR to decrease is always abnormal and implies pulmonary vascular disease ryawgtjskc (snxvwnifrp ) View more | - | 19 May 2024 | |||
NEWS Manual | Not Applicable | 635 | 他达拉非5mg每日一次 | ooaxnywtzu(gjuukbruwj) = kucaddsrmi akziwywxsr (ucyroqxqjb ) View more | Positive | 13 Mar 2024 | |
Not Applicable | - | Tadalafil 0.6 mg/Kg | fngbrbssrt(tbhckwqlhi) = oaszblsfkb pzsssxyqxx (wsuaziagwk, 0.8) | - | 03 Mar 2024 | ||
(Unaffected controls) | fngbrbssrt(tbhckwqlhi) = jufihrbmpj pzsssxyqxx (wsuaziagwk, 1.7) |