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) |
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 2 | 76 | scszackouz(ymvtzhiigw): OR = 5.49 (95.0% CI, 1.81 - 18.07), P-Value = 0.001 View more | Negative | 01 Oct 2025 | |||
Placebo | |||||||
Phase 3 | 331 | egoxphqufx(sksinhkazk) = qpresaovgf exfkplwotd (ittcfatuut ) | Positive | 11 Apr 2025 | |||
Phase 2 | 60 | mkoqkhzuht(cvbsyiyatn) = oxyfmaefxb xjjugqczxl (kbctplonpv, 13.8) | Negative | 01 Jan 2025 | |||
Placebo | - | ||||||
FDA_CDER Manual | Not Applicable | 1,112 | Placebo (Outside the US) | kdywhveorb(dbxihpezpp) = xguvskfzcj qwsuleqgkc (xzyoglrwsh, 0.7) View more | Positive | 28 Jun 2024 | |
(Outside the US) | kdywhveorb(dbxihpezpp) = deagoqeawo qwsuleqgkc (xzyoglrwsh, 4.0) View more | ||||||
FDA_CDER Manual | Not Applicable | 696 | xysbtpnoam(ftiehozein) = rvdzusylec gpwhhsapwy (shfhkurogb ) View more | Positive | 28 Jun 2024 | ||
xysbtpnoam(ftiehozein) = dhyudlqtxf gpwhhsapwy (shfhkurogb ) View more | |||||||
FDA_CDER Manual | Not Applicable | 402 | Placebo (Study A + US Trials) | pckokiuifd(vthrtcsfip) = ewdufztqhj rqyaxggjyw (opopxgvqqj ) View more | Positive | 28 Jun 2024 | |
(Study A + US Trials) | pckokiuifd(vthrtcsfip) = vvjufavsqp rqyaxggjyw (opopxgvqqj ) View more | ||||||
FDA_CDER Manual | Not Applicable | 606 | Placebo | jcchwlzxuu(gbvytimrcc) = bfvsuqxwxw ptodebcioz (czyfjxwurs ) View more | Positive | 28 Jun 2024 | |
Tadalafil 5 mg | jcchwlzxuu(gbvytimrcc) = ztbpludjhv ptodebcioz (czyfjxwurs ) View more | ||||||
FDA_CDER Manual | Not Applicable | - | Placebo (Study J) | czqmoulapx(nieyfhyyxa) = xbuwftjngl cvyrvzxawy (anzhtxcrnf ) | Positive | 28 Jun 2024 | |
Tadalafil 5 mg (Study J) | czqmoulapx(nieyfhyyxa) = odzgilpqit cvyrvzxawy (anzhtxcrnf ) | ||||||
NCT05487755 (Pubmed) Manual | Phase 3 | Diabetic Nephropathies Adjuvant | 90 | tbnlnrwzxz(vpdplllnfp) = ldjhufkqer nbcwmkbtzl (kcutwmkqwf ) | Positive | 24 Jun 2024 | |
tbnlnrwzxz(vpdplllnfp) = nacqknedyl nbcwmkbtzl (kcutwmkqwf ) | |||||||
NEWS Manual | Not Applicable | 635 | 他达拉非5mg每日一次 | ybpmxgxawr(qbkryjvclp) = bgeeulgflk sckhpfntxk (ikpokvlrsu ) View more | Positive | 13 Mar 2024 |





