Overview
Tadalafil is a selective phosphodiesterase-5 inhibitor that is used in the treatment of erectile dysfunction (ED), pulmonary arterial hypertension (PAH), and benign prostatic hypertrophy. It was first approved in 2003 by the FDA for use in ED and later in 2009 for PAH. In contrast to other PDE5 inhibitors like sildenafil, tadalafil has greater selectivity for PDE5 and a longer half-life which has made it a more suitable option for chronic once-daily dosing in the treatment of PAH.
Indication
Tadalafil is indicated for the treatment of erectile dysfunction (ED) and either alone or in combination with finasteride for the treatment of benign prostatic hypertrophy (BPH). It is also indicated for the treatment of pulmonary arterial hypertension (PAH) both alone and in combination with macitentan or other endothelin-1 antagonists.
Associated Conditions
- Benign Prostatic Hyperplasia (BPH)
- Erectile Dysfunction
- Pulmonary Arterial Hypertension (PAH)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/05/13 | Not Applicable | Not yet recruiting | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||
2025/04/27 | Phase 4 | Completed | |||
2025/02/05 | Phase 4 | Completed | |||
2025/01/23 | N/A | Completed | |||
2024/09/04 | Phase 2 | Recruiting | Aswan University Hospital | ||
2024/08/09 | Not Applicable | Completed | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||
2024/07/25 | Phase 3 | Recruiting | |||
2024/06/20 | Phase 3 | Completed | |||
2024/04/05 | Not Applicable | Recruiting | |||
2024/03/04 | Phase 2 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Bryant Ranch Prepack | 71335-1587 | ORAL | 20 mg in 1 1 | 6/16/2021 | |
| NorthStar RxLLC | 16714-076 | ORAL | 10 mg in 1 1 | 11/10/2023 | |
| Torrent Pharmaceuticals Limited | 13668-565 | ORAL | 2.5 mg in 1 1 | 11/17/2022 | |
| Aphena Pharma Solutions - Tennessee, LLC | 71610-303 | ORAL | 20 mg in 1 1 | 3/22/2019 | |
| Torrent Pharmaceuticals Limited | 13668-567 | ORAL | 10 mg in 1 1 | 11/17/2022 | |
| Aphena Pharma Solutions - Tennessee, LLC | 71610-325 | ORAL | 20 mg in 1 1 | 8/22/2019 | |
| Unichem Pharmaceuticals (USA), Inc. | 29300-287 | ORAL | 5 mg in 1 1 | 1/31/2024 | |
| PD-Rx Pharmaceuticals, Inc. | 72789-407 | ORAL | 5 mg in 1 1 | 4/8/2025 | |
| Northwind Pharmaceuticals, LLC | 82868-028 | ORAL | 20 mg in 1 1 | 1/1/2024 | |
| AvKARE | 42291-865 | ORAL | 5 mg in 1 1 | 1/10/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 9/27/2024 | ||
Authorised | 3/22/2017 | ||
Authorised | 11/21/2014 | ||
Authorised | 10/1/2008 | ||
Authorised | 11/12/2002 | ||
Authorised | 1/9/2017 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| TADAFIL 10 TADALAFIL TABLETS USP 10 MG | SIN16132P | TABLET, FILM COATED | 10.000mg | 3/23/2021 | |
| CIALIS TABLET 5 mg | SIN13632P | TABLET, FILM COATED | 5 mg | 4/23/2009 | |
| TALIS 20 - TADALAFIL TABLETS USP 20MG | SIN16156P | TABLET, FILM COATED | 20mg | 4/21/2021 | |
| TADAFIL 5 TADALAFIL TABLETS USP 5 MG | SIN16133P | TABLET, FILM COATED | 5.000mg | 3/23/2021 | |
| A-TADALAFIL FILM-COATED TABLETS 2.5 MG | SIN16937P | TABLET, FILM COATED | 2.5mg | 1/26/2024 | |
| CALIBERI ORODISPERSIBLE FILM 5MG | SIN15899P | FILM, SOLUBLE | 5mg | 3/9/2020 | |
| CALIBERI ORODISPERSIBLE FILM 20MG | SIN15898P | FILM, SOLUBLE | 20mg | 3/9/2020 | |
| TADAFIL 20 TADALAFIL TABLETS USP 20 MG | SIN16131P | TABLET, FILM COATED | 20.000mg | 3/23/2021 | |
| TADAFIL 2.5 TADALAFIL TABLETS USP 2.5 MG | SIN16134P | TABLET, FILM COATED | 2.500mg | 3/23/2021 | |
| CIALJUB FILM COATED TABLET 20MG | SIN16796P | TABLET, FILM COATED | 20 mg | 5/26/2023 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| TADALA TABLETS 5MG | N/A | N/A | N/A | 11/27/2024 | |
| TADALA TABLETS 20MG | N/A | N/A | N/A | 11/27/2024 | |
| HITALIS TABLETS 20MG | N/A | N/A | N/A | 6/28/2019 | |
| PROFORTE TABLETS 20MG | N/A | N/A | N/A | 7/7/2020 | |
| HAPPILONG TABLETS 5MG | N/A | N/A | N/A | 11/6/2023 | |
| TADEN TABLETS 20MG | N/A | N/A | N/A | 4/1/2025 | |
| ECKERD TADALAFIL TABLETS 20MG | N/A | N/A | N/A | 5/29/2025 | |
| OSCO TADALAFIL TABLETS 20MG | N/A | N/A | N/A | 5/29/2025 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| TADALAFIL-RZ tadalafil 5 mg film-coated tablet blister pack | 300367 | Medicine | A | 2/13/2020 | |
| TADALCA tadalafil 20 mg film-coated tablet blister pack | 282111 | Medicine | A | 1/15/2018 | |
| TADALAFIL-RZ tadalafil 20 mg film-coated tablet bottle | 285595 | Medicine | A | 3/2/2018 | |
| TADALAFIL APOTEX tadalafil 10mg tablet blister pack | 205880 | Medicine | A | 12/18/2013 | |
| Tadalafil-WGR tadalafil 20mg film-coated tablet blister pack | 277544 | Medicine | A | 5/26/2017 | |
| Tadalafil Alphapharm tadalafil 5mg film-coated tablets blister pack | 215925 | Medicine | A | 2/3/2021 | |
| Tadalafil Alphapharm tadalafil 5mg film-coated tablets bottle | 215922 | Medicine | A | 2/3/2021 | |
| ADIR TADALAFIL tadalafil 10 mg film-coated tablet blister pack | 313094 | Medicine | A | 5/12/2020 | |
| TADACIP 10 tadalafil 10 mg film-coated tablet blister pack | 274224 | Medicine | A | 3/27/2017 | |
| TADALAFIL ARW tadalafil 10mg film-coated tablet blister pack | 277554 | Medicine | A | 5/26/2017 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| BIO-TADALAFIL | biomed pharma | 02508702 | Tablet - Oral | 5 MG | N/A |
| AG-TADALAFIL | angita pharma inc. | N/A | Tablet - Oral | 20 MG | 11/21/2019 |
| M-TADALAFIL | mantra pharma inc | 02512130 | Tablet - Oral | 20 MG | 9/27/2021 |
| IPG-TADALAFIL | marcan pharmaceuticals inc | 02448653 | Tablet - Oral | 2.5 MG | N/A |
| NRA-TADALAFIL TABLETS | nora pharma inc | 02452499 | Tablet - Oral | 10 MG | 7/13/2016 |
| NRA-TADALAFIL | nora pharma inc | 02520923 | Tablet - Oral | 2.5 MG | N/A |
| UPH-TADALAFIL | uphealth pharma inc. | 02544385 | Tablet - Oral | 2.5 MG | N/A |
| TADALAFIL | PRO DOC LIMITEE | 02455374 | Tablet - Oral | 20 MG | 8/11/2016 |
| TADALAFIL | sivem pharmaceuticals ulc | 02536684 | Tablet - Oral | 5 MG | 8/29/2024 |
| MINT-TADALAFIL | mint pharmaceuticals inc | 02451689 | Tablet - Oral | 10 MG | 4/6/2023 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| ACORE 20 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Gp Pharm S.A. | 84403 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| QIZERZ 20 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Sandoz Farmaceutica S.A. | 81760 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Uso Hospitalario | Commercialized |
| TADALAFILO TECNIGEN 5 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Tecnimede España Industria Farmaceutica S.A. | 82813 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| TADALAFILO ALMUS 20 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Almus Farmaceutica S.A.U. | 88327 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| TADALAFILO MABO 5 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Mabo Farma S.A. | 82245 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| ALNEO 5 MG COMPRIMIDOS BUCODISPERSABLES EFG | Laboratorios Alter S.A. | 89636 | COMPRIMIDO BUCODISPERSABLE | Medicamento Sujeto A Prescripción Médica | Commercialized |
| TADALAFILO HEC PHARM 20 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Hec Pharm Gmbh | 85509 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| CIALIS 20 mg COMPRIMIDOS RECUBIERTOS CON PELICULA | 02237003 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| VICTOGON 20 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Laboratorios Normon S.A. | 83614 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| ALNEO 5 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Laboratorios Alter S.A. | 84852 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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