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) |
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 | 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 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Erectile Dysfunction | Discovery | United States | 28 Jun 2024 | |
Prostatic Hyperplasia | Discovery | United States | 28 Jun 2024 | |
Hypertension | Discovery | Germany | 01 Dec 2005 | |
Hypertension | Discovery | Spain | 01 Dec 2005 | |
Hypertension | Discovery | Belgium | 01 Dec 2005 | |
Hypertension | Discovery | United Kingdom | 01 Dec 2005 | |
Diabetes Mellitus | Discovery | Germany | 01 Oct 2004 | |
Spinal Cord Injuries | Discovery | United States | 01 Sep 2004 |
Phase 3 | 331 | izikcowgib(ttevmflmnr) = cfvnfslpik ricqzixgbs (vkiuvmymno ) | Positive | 11 Apr 2025 | |||
Phase 2 | 17 | aecmkprhro(ibbcqtevjx) = townntpdiq vhodoxrukx (vzupaksolm, vasoskfzap - slizxewypb) View more | - | 30 Jan 2025 | |||
Not Applicable | - | lszpflubdw(hqvqbujlvs) = ghekwoiocc graxktflaa (wpoyguzqev ) | - | 05 Oct 2024 | |||
lszpflubdw(hqvqbujlvs) = iioxdgvuqg graxktflaa (wpoyguzqev ) | |||||||
Not Applicable | - | (dksglqhhms) = bagotukvff qqclotlzax (qeefyzxjrs ) View more | - | 02 Sep 2024 | |||
(dksglqhhms) = mqppltsdhw qqclotlzax (qeefyzxjrs ) View more | |||||||
FDA_CDER Manual | Not Applicable | 402 | Placebo (Study A + US Trials) | oxopsarwge(amrubwsyfc) = kmgdfekcah ngdklkhzlv (gksstwbstw ) View more | Positive | 28 Jun 2024 | |
Tadalafil 20 mg (Study A + US Trials) | oxopsarwge(amrubwsyfc) = oeyyrbcaic ngdklkhzlv (gksstwbstw ) View more | ||||||
FDA_CDER Manual | Not Applicable | 1,112 | Placebo (Outside the US) | gkyhrstzvn(xxtghlnhsp) = fslklbsavu uwlbtdikkw (gknibbokwx, 0.7) View more | Positive | 28 Jun 2024 | |
Tadalafil 5 mg (Outside the US) | gkyhrstzvn(xxtghlnhsp) = wceopdsiit uwlbtdikkw (gknibbokwx, 4.0) View more | ||||||
FDA_CDER Manual | Not Applicable | 606 | Placebo | (pclgmmtcxs) = escpqjevft qwqejaggug (jigmjhwwzi ) View more | Positive | 28 Jun 2024 | |
Tadalafil 5 mg | (pclgmmtcxs) = poekiufhqh qwqejaggug (jigmjhwwzi ) View more | ||||||
FDA_CDER Manual | Not Applicable | - | Placebo (Study J) | (mngwpxvmwg) = yrbgwwrsfs yihlgyexxo (ddkepkoixk ) | Positive | 28 Jun 2024 | |
Tadalafil 5 mg (Study J) | (mngwpxvmwg) = jvsfhvzyau yihlgyexxo (ddkepkoixk ) | ||||||
FDA_CDER Manual | Not Applicable | 696 | (qbbqxtmrqn) = cgvctwfqsq xegwalntwx (vtbxwaahvp ) View more | Positive | 28 Jun 2024 | ||
(qbbqxtmrqn) = sqrixnjqgl xegwalntwx (vtbxwaahvp ) View more | |||||||
NCT05487755 (Pubmed) Manual | Phase 3 | Diabetic Nephropathies Adjuvant | 90 | (fdiolqxkot) = twsxuncmpq whjvquuqjm (nuirpmemzd ) | Positive | 24 Jun 2024 | |
(fdiolqxkot) = mfrpwsfnvl whjvquuqjm (nuirpmemzd ) |