Drugs / Tadalafil
Tadalafil
also known as
Cialis · TAD · Adcirca · Adcirca (previously tadalafil lilly) · Chewtadzy · IC-351 · LY-450190 · NSC-750236 · +10 more
Small molecule targets PDE5A
Regulatory milestones approvals, filings & regulatory actions · 13 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed benign prostatic hyperplasia 1 milestone | |||||
| Filed | US (FDA) | Cialis | benign prostatic hyperplasia | — | “submitted to the U.S. Food and Drug Administration (FDA) last year seeking approval for Cialis in the treatment of the signs and symptoms of BPH” lilly.com ↗ |
| Filed erectile dysfunction 3 milestones | |||||
| Filed | US (FDA) | Cialis | erectile dysfunction | 2001-07-18 | “FDA) and European Agency for the Evaluation of Medicinal Products (EMEA) requesting marketing approval of CialisTM (IC351) for the treatment of ED.” lilly.com ↗ |
| Filed | EU (EMA) | Cialis | erectile dysfunction | 2001-07-18 | “FDA) and European Agency for the Evaluation of Medicinal Products (EMEA) requesting marketing approval of CialisTM (IC351) for the treatment of ED.” lilly.com ↗ |
| Filed | Japan (PMDA) | Cialis | erectile dysfunction | — | “our recent submissions of Byetta(R) in Europe for type 2 diabetes, Cialis(R) in Japan for erectile dysfunction” lilly.com ↗ |
| Filed pulmonary arterial hypertension 2 milestones | |||||
| Filed | US (FDA) | — | pulmonary arterial hypertension | 2008-10-23 | “The company submitted tadalafil as a treatment for pulmonary arterial hypertension (PAH) to regulatory authorities in both the United States and Japan.” lilly.com ↗ |
| Filed | Japan (PMDA) | — | pulmonary arterial hypertension | 2008-10-23 | “The company submitted tadalafil as a treatment for pulmonary arterial hypertension (PAH) to regulatory authorities in both the United States and Japan.” lilly.com ↗ |
| Approved Indication not stated 4 milestones | |||||
| Rejected (CRL) | US (FDA) | — | — | 2018-11-16 | “complete response letter (CRL) from the U.S. Food and Drug Administration ( FDA ) in regards to its New Drug Application (NDA) for tadalafil oral film” aquestive.com ↗ |
| Label expansions (4) | US (FDA) | CIALIS | — | 2008-01-07 – 2018-02-15 | fda.gov ↗ |
| Approved | US (FDA) | CIALIS | — | 2003-11-21 | fda.gov ↗ |
| Approved | EU (EMA) | Cialis | — | 2002-11-12 | europa.eu ↗ |
Trials 146 · started per year
today
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US approved 2003
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 03 trials | ||||||
| Phase 0 | NCT05466695 | Aug 2022 → Jul 2023 | — | Assiut University | Unknown | No outcome recorded |
| Phase 0 | NCT03238365 | Aug 2017 → Jul 2019 | head and neck carcinoma, laryngeal disorder | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University | Completed | No outcome recorded |
| Phase 0 | NCT01359670 | May 2011 → May 2013 | Duchenne muscular dystrophy | Cedars-Sinai Medical Center | Completed | No outcome recorded |
| Phase 126 trials · 2 met primary | ||||||
| Phase 1 | NCT07117383 | Jan → Mar 2026 overdue | erectile dysfunction | Aspargo Labs, Inc | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT04762082 | May → Aug 2025 | erectile dysfunction | Seattle Gummy Company | Unknown | No outcome recorded |
| Phase 1 | NCT06553924 | May 2024 | pulmonary arterial hypertension | Humanis | Completed | No outcome recorded |
| Phase 1 | NCT05236231 | Feb → May 2022 | — | Actelion | Completed | No outcome recorded |
| Phase 1 | NCT05095077 | Aug → Dec 2021 | female stress incontinence | University Hospital Bispebjerg and Frederiksberg | Completed | No outcome recorded |
| Phase 1 | NCT04757662 | May 2021 → Jun 2023 | astrocytoma (excluding glioblastoma) | Washington University School of Medicine | Completed | No outcome recorded |
| Phase 1 | NCT04540744 | Apr → Aug 2021 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT04235270 | Jan → Jul 2020 | — | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 1 | NCT02998736 | Nov 2017 → Sep 2022 | digestive system cancer | Ottawa Hospital Research Institute | Completed | No outcome recorded |
| Phase 1 | NCT03215966 | Aug → Sep 2017 | — | Actelion | Completed | No outcome recorded |
| Phase 1 | NCT02839122 | May → Sep 2016 | benign prostatic hyperplasia | Yuyu Pharma, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02544880 | Apr 2016 → Jun 2019 | head and neck squamous cell carcinoma | Donald T. Weed, MD, FACS | Completed | No outcome recorded |
| Phase 1 | NCT02688387 | Mar 2016 → Aug 2017 | pulmonary hypertension | GlaxoSmithKline | Completed | Met primary |
| Phase 1 | NCT02615782 | Dec 2015 → Apr 2016 | benign prostatic hyperplasia | Chong Kun Dang Pharmaceutical | Completed | No outcome recorded |
| Phase 1 | NCT02352311 | Jan → Jun 2015 | benign prostatic hyperplasia | Dongkook Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT02300259 | Nov 2014 → Apr 2015 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT02247505 | Sep → Oct 2014 | — | Chong Kun Dang Pharmaceutical | Completed | No outcome recorded |
| Phase 1 | NCT02239484 | Mar → Sep 2014 | benign prostatic hyperplasia, erectile dysfunction | Hanmi Pharmaceutical Company Limited | Completed | No outcome recorded |
| Phase 1 | NCT01942551 | Sep → Dec 2013 | benign prostatic hyperplasia | Dongkook Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT01903083 | Jul 2013 → Dec 2017 | — | Providence Health & Services | Completed | No outcome recorded |
| Phase 1 | NCT01580501 | Mar 2012 → Mar 2013 | Duchenne muscular dystrophy | Cedars-Sinai Medical Center | Completed | No outcome recorded |
| Phase 1 | NCT01291069 | Sep 2011 → Feb 2014 | univentricular heart | University of Utah | Completed | No outcome recorded |
| Phase 1 | NCT01342224 | Jan 2011 → Jun 2012 | pancreatic adenocarcinoma | Providence Health & Services | Completed | No outcome recorded |
| Phase 1 | NCT01244620 | Nov → Dec 2010 | pulmonary arterial hypertension | Pfizer | Terminated | No outcome recorded |
| Phase 1 | NCT01183650 | Jul 2010 → Apr 2011 | benign prostatic hyperplasia | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT02253862 | Dec 2005 → Mar 2006 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1/25 trials · 1 met primary · 1 missed | ||||||
| Phase 1/2 | NCT07206706 | May → Dec 2022 | — | Ain Shams University | Completed | No outcome recorded |
| Phase 1/2 | NCT05030623 | Aug 2021 → Dec 2024 | major depressive disorder | Sadat City University | Withdrawn | No outcome recorded Stop: Business |
| Phase 1/2 | NCT01484431 | Jul 2012 → Apr 2017 | pulmonary arterial hypertension | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1/2 | NCT01544998 | Feb 2012 → Aug 2013 | congestive heart failure | Mayo Clinic | Completed | Missed primary |
| Phase 1/2 | NCT00274430 | Jul → Sep 2003 | high altitude pulmonary edema | University of Zurich | Completed | Met primary |
| Phase 225 trials · 5 missed | ||||||
| Phase 2 | NCT07576335 | Aug 2026 → Dec 2028 expected | prostate cancer | Surgical Outcomes Research Centre (SOuRCe) | Recruiting | No outcome recorded |
| Phase 2 | NCT06290713 | Jun 2024 → Nov 2026 expected | Duchenne muscular dystrophy | University of Florida | Recruiting | No outcome recorded |
| Phase 2 | NCT05709574 | Apr 2023 → Jun 2026 overdue | gastric adenocarcinoma, gastroesophageal junction adenocarcinoma | University of Arizona | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05014776 | Aug 2022 → Apr 2024 | malignant pancreatic neoplasm | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Completed | No outcome recorded |
| Phase 2 | NCT05173896 | May 2022 → Sep 2024 overdue | ischemic stroke | Christina Kruuse | Active not recruiting | Missed primary |
| Phase 2 | NCT05142254 | Apr 2022 → Jul 2023 | priapism | Vanderbilt University Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT03993353 | Apr 2020 → Apr 2022 | esophageal cancer, head and neck squamous cell carcinoma, malignant tumor of neck, metastatic malignant neoplasm +1 | University of California, San Diego | Completed | No outcome recorded |
| Phase 2 | NCT07333976 | Jan 2020 → Dec 2023 | chemotherapy-induced neuropathy, metastatic prostate carcinoma, toxic polyneuropathy | Tri-Service General Hospital (TSGH) | Completed | No outcome recorded |
| Phase 2 | NCT04069936 | Oct 2019 → Oct 2021 | non-small cell lung carcinoma | WindMIL Therapeutics | Terminated | No outcome recorded |
| Phase 2 | NCT03785210 | Jun 2019 → Oct 2022 | colorectal cancer, hepatocellular carcinoma, malignant pancreatic neoplasm | National Cancer Institute (NCI) | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02611336 | Jul 2016 → Jan 2021 | acromegaly | Andrea M. Isidori | Completed | No outcome recorded |
| Phase 2 | NCT02611258 | Jul 2016 → Jan 2021 | intrinsic cardiomyopathy | Andrea M. Isidori | Completed | No outcome recorded |
| Phase 2 | NCT02601989 | Nov 2015 → Jan 2019 | type 2 diabetes mellitus | Göteborg University | Completed | Missed primary |
| Phase 2 | NCT02194465 | Aug 2014 → Mar 2015 | essential hypertension | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT01862536 | Oct 2013 → Aug 2019 | chronic obstructive pulmonary disease, pulmonary hypertension owing to lung disease and/or hypoxia | VA Office of Research and Development | Completed | No outcome recorded |
| Phase 2 | NCT01374217 | Apr 2012 → Jan 2014 | plasma cell myeloma | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Terminated | No outcome recorded |
| Phase 2 | NCT01160289 | Oct 2010 → Nov 2011 | erectile dysfunction | Eli Lilly and Company | Completed | Missed primary |
| Phase 2 | NCT00783094 | Nov 2008 → Jun 2009 | benign prostatic hyperplasia | Eli Lilly and Company | Completed | Missed primary |
| Phase 2 | NCT00540124 | Oct 2007 → Jun 2008 | benign prostatic hyperplasia | Eli Lilly and Company | Completed | Missed primary |
| Phase 2 | NCT00894413 | May 2007 → Mar 2012 | head and neck squamous cell carcinoma | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Completed | No outcome recorded |
| Phase 2 | NCT00538564 | Nov 2006 → Aug 2009 | priapism, sickle cell disease | Johns Hopkins University | Withdrawn | No outcome recorded |
| Phase 2 | NCT00157326 | Sep 2005 → Jun 2006 | hypertensive disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT00174486 | Feb → Jun 2005 | erectile dysfunction | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00707187 | Jul 2001 → Jul 2002 | systemic sclerosis | University of Medicine and Dentistry of New Jersey | Completed | No outcome recorded |
| Phase 2 | NCT00334477 | — | erectile dysfunction | University of Pernambuco | Unknown | No outcome recorded |
| Phase 2/35 trials · 1 missed | ||||||
| Phase 2/3 | NCT06583590 | Aug 2024 → Aug 2025 overdue | erectile dysfunction | Aswan University Hospital | Recruiting | No outcome recorded |
| Phase 2/3 | NCT05971667 | Jul → Oct 2023 | — | Beni-Suef University | Unknown | No outcome recorded |
| Phase 2/3 | NCT05955001 | Apr 2023 → Jul 2025 overdue | erectile dysfunction | Mansoura University | Recruiting | No outcome recorded |
| Phase 2/3 | NCT05195775 | Dec 2021 → Sep 2025 overdue | Duchenne muscular dystrophy | University of Florida | Active not recruiting | No outcome recorded |
| Phase 2/3 | NCT01324999 | Mar 2011 → Jul 2013 | pulmonary hypertension | University of North Carolina, Chapel Hill | Completed | Missed primary |
| Phase 333 trials · 11 met primary · 4 missed | ||||||
| Phase 3 | NCT06805513 | Jan 2025 → Mar 2026 | erectile dysfunction | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT06520839 | May → Dec 2024 overdue | erectile dysfunction | University Medical Centre Ljubljana | Recruiting | No outcome recorded |
| Phase 3 | NCT06466369 | Mar → Jul 2024 | benign prostatic hyperplasia | Al-Azhar University | Completed | No outcome recorded |
| Phase 3 | NCT05844462 | Feb 2024 → Sep 2027 expected | chronic obstructive pulmonary disease, pulmonary hypertension | Assistance Publique - Hôpitaux de Paris | Recruiting | No outcome recorded |
| Phase 3 | NCT06707181 | Nov 2023 → May 2024 | ureterolithiasis | Beni-Suef University | Completed | No outcome recorded |
| Phase 3 | NCT05206955 | Sep 2022 → Nov 2026 expected | univentricular cardiopathy | Mayo Clinic | Recruiting | No outcome recorded |
| Phase 3 | NCT05179876 | May 2022 → Jan 2027 expected | pulmonary hypertension | Actelion | Recruiting | No outcome recorded |
| Phase 3 | NCT05487755 | Feb 2022 → Mar 2023 | diabetic kidney disease | Tanta University | Completed | Met primary |
| Phase 3 | NCT04984993 | Sep 2021 → Jul 2022 | erectile dysfunction | Futura Medical Developments Ltd. | Completed | Met primary |
| Phase 3 | NCT04361305 | Jun 2020 → Jan 2021 | erectile dysfunction, premature ejaculation | Yan-Ping Huang | Unknown | No outcome recorded |
| Phase 3 | NCT03904693 | Jul 2019 → Aug 2022 | pulmonary arterial hypertension | Actelion | Completed | Met primary |
| Phase 3 | NCT04052269 | Jun 2019 → Oct 2021 | glaucoma | Imperial College London | Suspended | No outcome recorded |
| Phase 3 | NCT03905018 | May → Sep 2019 | — | Centro Universitario de Ciencias de la Salud, Mexico | Unknown | No outcome recorded |
| Phase 3 | NCT03246880 | Sep 2015 → Apr 2016 | benign prostatic hyperplasia | Chong Kun Dang Pharmaceutical | Completed | No outcome recorded |
| Phase 3 | NCT01824290 | Feb 2014 → Mar 2019 | pulmonary arterial hypertension | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT01960153 | Oct 2013 → Dec 2017 | heart failure, pulmonary hypertension | Massachusetts General Hospital | Withdrawn | No outcome recorded |
| Phase 3 | NCT01937871 | Sep 2013 → Dec 2015 | benign prostatic hyperplasia, erectile dysfunction | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT01865084 | Sep 2013 → Dec 2015 | Duchenne muscular dystrophy | Eli Lilly and Company | Terminated | Missed primary |
| Phase 3 | NCT01460342 | Dec 2011 → Oct 2012 | benign prostatic hyperplasia | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT01152190 | Sep 2010 → Jul 2012 | benign prostatic hyperplasia | Eli Lilly and Company | Completed | Missed primary |
| Phase 3 | NCT01139762 | Sep 2010 → Feb 2012 | benign prostatic hyperplasia | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT01117298 | Nov 2009 → Apr 2010 | Raynaud disease, scleroderma | Sanjay Gandhi Postgraduate Institute of Medical Sciences | Completed | No outcome recorded |
| Phase 3 | NCT00931528 | Nov 2009 → Dec 2012 | prostate cancer, sexual disorder | Radiation Therapy Oncology Group | Completed | Missed primary |
| Phase 3 | NCT00970632 | Oct 2009 → Jan 2011 | benign prostatic hyperplasia | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT00861757 | Mar 2009 → Jun 2010 | benign prostatic hyperplasia | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT00848081 | Mar → Dec 2009 | benign prostatic hyperplasia | Eli Lilly and Company | Completed | Missed primary |
| Phase 3 | NCT00855582 | Mar 2009 → Jul 2010 | benign prostatic hyperplasia, erectile dysfunction | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00827242 | Jan → Nov 2009 | benign prostatic hyperplasia | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT00836693 | Jan 2009 → Jan 2010 | erectile dysfunction | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT00734604 | Aug 2008 → Sep 2009 | erectile dysfunction | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT00215631 | Oct → Nov 2005 | erectile dysfunction, prostate cancer | Erasmus Medical Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00421083 | Sep 2004 → Jun 2005 | erectile dysfunction, spinal cord injury | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00122499 | Feb 2003 → Feb 2005 | erectile dysfunction, prostate cancer | Erasmus Medical Center | Completed | No outcome recorded |
| Phase 432 trials · 4 met primary · 2 missed | ||||||
| Phase 4 | NCT07753720 | Aug 2026 → Jun 2027 expected | erectile dysfunction | Al-Azhar University | Recruiting | No outcome recorded |
| Phase 4 | NCT07642505 | Jun → Nov 2026 expected | erectile dysfunction | Beni-Suef University | Recruiting | No outcome recorded |
| Phase 4 | NCT07654413 | Jun 2026 → Nov 2027 expected | benign prostatic hyperplasia, urinary tract obstruction | Beni-Suef University | Recruiting | No outcome recorded |
| Phase 4 | NCT07391579 | Dec 2025 → Dec 2026 expected | erectile dysfunction | Mansoura University | Recruiting | No outcome recorded |
| Phase 4 | NCT07416968 | Sep 2025 → Sep 2026 overdue | overactive bladder | Mansoura University | Recruiting | No outcome recorded |
| Phase 4 | NCT07574268 | May 2025 → Jan 2026 | erectile dysfunction | Menoufia University | Completed | No outcome recorded |
| Phase 4 | NCT07602608 | Apr → Dec 2025 | erectile dysfunction | Benha University | Completed | No outcome recorded |
| Phase 4 | NCT06947265 | Jan 2024 → Jan 2025 | erectile dysfunction | Fayoum University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT07499804 | Oct 2023 → Apr 2026 overdue | female infertility | Beni-Suef University | Recruiting | No outcome recorded |
| Phase 4 | NCT06809205 | Apr 2023 → May 2024 | benign prostatic hyperplasia | Fayoum University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT03177746 | Dec 2022 → Jan 2023 | erectile dysfunction, premature ejaculation | Neutec Ar-Ge San ve Tic A.Ş | Unknown | No outcome recorded |
| Phase 4 | NCT05051436 | Dec 2021 → Jan 2027 expected | obesity disorder, prediabetes syndrome | Philip Kern | Recruiting | No outcome recorded |
| Phase 4 | NCT04946162 | Apr 2020 | COVID-19, acute respiratory distress syndrome | Santa Barbara Cottage Hospital | Withdrawn | No outcome recorded |
| Phase 4 | NCT03309592 | Oct 2017 → Nov 2018 | cirrhosis of liver, pulmonary hypertension | Ochsner Health System | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT02943356 | Jul 2016 → Jul 2017 | erectile dysfunction, hypogonadism, male | The Catholic University of Korea | Unknown | No outcome recorded |
| Phase 4 | NCT02252367 | Dec 2015 → Jan 2019 | benign prostatic hyperplasia | University of Florence | Completed | No outcome recorded |
| Phase 4 | NCT02968901 | Sep 2015 → Sep 2018 | pulmonary arterial hypertension | Actelion | Terminated | No outcome recorded |
| Phase 4 | NCT02595684 | Aug → Nov 2015 | obesity disorder | University of Guadalajara | Completed | No outcome recorded |
| Phase 4 | NCT02431754 | Apr 2015 → Feb 2016 | benign prostatic hyperplasia | Eli Lilly and Company | Completed | Missed primary |
| Phase 4 | NCT02224846 | Oct 2014 → May 2016 | erectile dysfunction | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 4 | NCT03236818 | May 2013 → Sep 2017 | pulmonary arterial hypertension | Amsterdam UMC, location VUmc | Unknown | No outcome recorded |
| Phase 4 | NCT01352507 | Jun 2011 → Jun 2012 | erectile dysfunction | Eli Lilly and Company | Completed | Met primary |
| Phase 4 | NCT01326117 | Apr 2011 → Dec 2013 | gastroparesis | Mark Feinglos | Withdrawn | No outcome recorded |
| Phase 4 | NCT01122264 | May 2010 → Jun 2011 | erectile dysfunction | Eli Lilly and Company | Completed | Met primary |
| Phase 4 | NCT01070511 | Jan 2010 → Dec 2012 | Becker muscular dystrophy | Cedars-Sinai Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT01042158 | Jan 2010 → Nov 2014 | pulmonary arterial hypertension, systemic sclerosis | Johns Hopkins University | Completed | Met primary |
| Phase 4 | NCT01026818 | Nov 2009 → Oct 2012 | erectile dysfunction | Eli Lilly and Company | Completed | Missed primary |
| Phase 4 | NCT00833638 | Feb → Jun 2009 | erectile dysfunction | Eli Lilly and Company | Completed | Met primary |
| Phase 4 | NCT00705588 | Aug 2008 → Jan 2010 | pulmonary arterial hypertension | Rabin Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT00333281 | Jun 2005 → Aug 2006 | erectile dysfunction | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 4 | NCT00422578 | Oct 2004 → Sep 2005 | erectile dysfunction | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 4 | NCT07715448 | ? → Jan 2026 | benign prostatic hyperplasia, erectile dysfunction | Beni-Suef University | Completed | No outcome recorded |
| Phase not applicable17 trials · 1 met primary | ||||||
| — | NCT07707505 | Aug 2026 → Jan 2027 expected | — | Medipol University | Not yet recruiting | No outcome recorded |
| — | NCT07690566 | Sep → Dec 2025 | — | Deraya University | Completed | No outcome recorded |
| — | NCT07312955 | May → Nov 2025 | overactive bladder | Ain Shams University | Completed | No outcome recorded |
| — | NCT06968962 | May 2025 → May 2028 expected | pulmonary arterial hypertension | Second Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting | No outcome recorded |
| — | NCT06962462 | May → Aug 2025 overdue | diabetes mellitus type 2 associated cataract | South Valley University | Not yet recruiting | No outcome recorded |
| — | NCT06543628 | Aug 2024 → Mar 2025 | erectile dysfunction | Second Affiliated Hospital, School of Medicine, Zhejiang University | Completed | No outcome recorded |
| — | NCT05823506 | Feb → Dec 2023 | erectile dysfunction | Saint Petersburg State University, Russia | Unknown | No outcome recorded |
| — | NCT05789732 | Mar → Aug 2022 | ureterolithiasis | Benha University | Completed | No outcome recorded |
| — | NCT05109377 | Jun → Nov 2021 | erectile dysfunction | Ankara Training and Research Hospital | Unknown | No outcome recorded |
| — | NCT03566914 | Jun 2018 → Dec 2019 | cirrhosis of liver | Institute of Liver and Biliary Sciences, India | Completed | Met primary |
| — | NCT02304679 | Jul 2015 → Feb 2018 | erectile dysfunction | Nîmes University Hospital | Completed | No outcome recorded |
| — | NCT01564303 | May → Nov 2012 | — | The Nazareth Hospital | Unknown | No outcome recorded |
| — | NCT00822354 | Sep 2008 → Feb 2010 | Raynaud disease | Northwestern University | Completed | No outcome recorded |
| — | NCT00843635 | Sep 2008 → Apr 2015 | head and neck cancer | Donald T. Weed | Completed | No outcome recorded |
| — | NCT00506701 | Feb 2008 → Feb 2010 | chronic obstructive pulmonary disease | Herlev Hospital | Withdrawn | No outcome recorded Stop: Business |
| — | NCT00463957 | Aug 2006 → ? | erectile dysfunction | University of Cambridge | Unknown | No outcome recorded |
| — | NCT01060969 | Jan 2006 → Aug 2010 | brain edema, pulmonary edema | Sheba Medical Center | Completed | No outcome recorded |
| Comparator or background therapy99 trials | ||||||
| Phase 0 | NCT07447518 Comparator | Sep 2022 → Jan 2023 | — | Kafrelsheikh University | Completed | No outcome recorded |
| Phase 0 | NCT02653833 Background | Nov 2017 → Sep 2018 | muscular dystrophy | Cedars-Sinai Medical Center | Terminated | No outcome recorded |
| Phase 1 | NCT07466030 Comparator | Mar 2026 → Mar 2028 expected | benign prostatic hyperplasia | Assiut University | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT04500860 Comparator | Dec 2020 → Jul 2022 | overactive bladder | Kasr El Aini Hospital | Completed | No outcome recorded |
| Phase 1 | NCT03166787 Background | Aug 2017 → Apr 2020 | — | Cedars-Sinai Medical Center | Terminated | No outcome recorded |
| Phase 1 | NCT03240939 Comparator | Mar → Jul 2017 | benign prostatic hyperplasia | Yuyu Pharma, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02645890 Comparator | Nov → Dec 2015 | benign prostatic hyperplasia | Chong Kun Dang Pharmaceutical | Completed | No outcome recorded |
| Phase 1 | NCT01401543 Comparator | Jul → Sep 2011 | erectile dysfunction | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01238224 Comparator | Nov 2009 → Nov 2011 | type 2 diabetes mellitus | Vastra Gotaland Region | Terminated | No outcome recorded |
| Phase 1/2 | NCT02058095 Comparator | Mar 2014 → Jun 2019 | cardiomyopathy, impaired renal function disease | Mayo Clinic | Completed | No outcome recorded |
| Phase 1/2 | NCT01970176 Comparator | Jan 2014 → Sep 2019 | cardiomyopathy, impaired renal function disease | Mayo Clinic | Completed | No outcome recorded |
| Phase 2 | NCT07537855 Background | Jun 2026 → Jun 2028 expected | erectile dysfunction | Northwestern University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07231185 Comparator | Jan → Mar 2026 overdue | erectile dysfunction | Aspargo Labs, Inc | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07172815 Comparator | Sep 2025 → Aug 2028 expected | Alzheimer disease | Imperial College London | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05937854 Comparator | Apr 2024 → Mar 2029 expected | chronic obstructive pulmonary disease, pulmonary hypertension | VA Office of Research and Development | Recruiting | No outcome recorded |
| Phase 2 | NCT05558007 Comparator | Nov 2023 → Dec 2024 overdue | erectile dysfunction, prostate cancer | Biozeus Biopharmaceutical S.A. | Recruiting | No outcome recorded |
| Phase 2 | NCT04684589 Comparator | Mar 2021 → Jun 2025 | obesity disorder | Vanderbilt University Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT04483115 Comparator | Nov 2020 → Jun 2022 | pulmonary arterial hypertension | Vigonvita Life Sciences | Completed | No outcome recorded |
| Phase 2 | NCT02801032 Comparator | Nov 2016 → Aug 2017 | stroke disorder | Christina Kruuse | Completed | No outcome recorded |
| Phase 2 | NCT02819440 Comparator | Jul 2016 → Jun 2020 | obesity disorder | Vanderbilt University Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT02450253 Comparator | Sep 2015 → Jan 2018 | vascular dementia | St George's, University of London | Completed | No outcome recorded |
| Phase 2 | NCT01697800 Comparator | Sep 2012 → Jul 2014 | head and neck squamous cell carcinoma | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Completed | No outcome recorded |
| Phase 2 | NCT01423370 Comparator | Nov 2011 → Mar 2013 | erectile dysfunction | Yuhan Corporation | Completed | No outcome recorded |
| Phase 2 | NCT01197469 Comparator | Sep 2010 → Sep 2012 | chronic obstructive pulmonary disease, pulmonary hypertension owing to lung disease and/or hypoxia | University of Dundee | Completed | No outcome recorded |
| Phase 2 | NCT01200732 Comparator | Feb 2008 → Jul 2010 | Eisenmenger syndrome | Govind Ballabh Pant Hospital | Completed | No outcome recorded |
| Phase 2 | NCT00386009 Comparator | Oct 2006 → May 2008 | benign prostatic hyperplasia | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT00547625 Comparator | Oct 2004 → Jul 2005 | benign prostatic hyperplasia | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT00050609 Comparator | Feb → Sep 2003 | gastroparesis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2/3 | NCT05266651 Comparator | Mar → May 2022 | sexual disorder | Kasr El Aini Hospital | Unknown | No outcome recorded |
| Phase 2/3 | NCT00384930 Comparator | Aug 2006 → Oct 2007 | benign prostatic hyperplasia | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT07245680 Background | Apr 2026 → Feb 2029 expected | pulmonary arterial hypertension | Assistance Publique - Hôpitaux de Paris | Recruiting | No outcome recorded |
| Phase 3 | NCT07177326 Comparator | Oct 2025 → Oct 2026 expected | erectile dysfunction | Assiut University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06717711 Background | Aug 2024 → Aug 2025 overdue | erectile dysfunction, malignant urinary system neoplasm, prostate carcinoma | Regina Elena Cancer Institute | Recruiting | No outcome recorded |
| Phase 3 | NCT05052879 Comparator | Jul 2024 → May 2026 overdue | erectile dysfunction, premature ejaculation | EMS | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT04947631 Comparator | Jul 2021 → Jun 2023 | benign prostatic hyperplasia | Dongkook Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT04433559 Comparator | Aug 2020 → Aug 2021 | psychosexual disorder | Lidia Larrañaga | Unknown | No outcome recorded |
| Phase 3 | NCT04703127 Comparator | Mar 2020 → Jan 2021 | premature ejaculation | Sohag University | Unknown | No outcome recorded |
| Phase 3 | NCT03049540 Comparator | Oct 2017 → Oct 2021 | congenital heart disease, congenitally corrected transposition of the great arteries | Insel Gruppe AG, University Hospital Bern | Completed | No outcome recorded |
| Phase 3 | NCT02558231 Background | May 2016 → Aug 2019 | pulmonary arterial hypertension | Actelion | Completed | Missed primary |
| Phase 3 | NCT02862483 Background | Mar 2016 → Mar 2017 | benign prostatic hyperplasia, erectile dysfunction | IlDong Pharmaceutical Co Ltd | Unknown | No outcome recorded |
| Phase 3 | NCT01910389 Comparator | Nov 2013 → Feb 2014 | heart failure, pulmonary hypertension | Carelon Research | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT01553981 Comparator | Mar 2012 → Apr 2014 | interstitial lung disease | Sanjay Gandhi Postgraduate Institute of Medical Sciences | Completed | No outcome recorded |
| Phase 3 | NCT01444651 Comparator | Aug 2011 → Mar 2013 | cardiovascular disorder, glucose intolerance, obesity disorder | Thomas J. Wang, MD | Completed | No outcome recorded |
| Phase 3 | NCT01178073 Comparator | Oct 2010 → Jul 2014 | pulmonary arterial hypertension | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01063855 Background | Apr 2010 → Aug 2011 | erectile dysfunction, sexual disorder | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | Met primary |
| Phase 3 | NCT00626665 Comparator | Dec 2007 → Apr 2008 | Raynaud disease | Sanjay Gandhi Postgraduate Institute of Medical Sciences | Completed | No outcome recorded |
| Phase 3 | NCT00422734 Comparator | Nov 2006 → Jan 2008 | erectile dysfunction | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00549302 Comparator | Dec 2005 → Feb 2012 | pulmonary arterial hypertension | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00125918 Comparator | Aug 2005 → Aug 2007 | pulmonary hypertension | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00547183 Comparator | Oct 2004 → May 2005 | erectile dysfunction | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00547495 Comparator | Mar → Nov 2004 | erectile dysfunction | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00668109 Comparator | Dec 2003 → Jun 2004 | erectile dysfunction | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT00381732 Comparator | Oct 2003 → Jun 2006 | erectile dysfunction | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00547417 Comparator | Jul 2003 → Mar 2004 | erectile dysfunction | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00547573 Comparator | Apr → Dec 2003 | erectile dysfunction | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00547287 Comparator | Nov 2002 → May 2004 | erectile dysfunction | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00547508 Comparator | Oct 2002 → Sep 2003 | erectile dysfunction | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 4 | NCT07636161 Background | Oct 2026 → Sep 2027 | type 2 diabetes mellitus | University of Miami | Suspended | No outcome recorded Stop: Business |
| Phase 4 | NCT07563647 Comparator | May 2025 → Mar 2026 | diastolic heart failure, erectile dysfunction, metabolic syndrome X | Kafrelsheikh University | Completed | No outcome recorded |
| Phase 4 | NCT06317805 Background | Dec 2023 → Jun 2027 expected | pulmonary arterial hypertension | AOP Orphan Pharmaceuticals AG | Recruiting | No outcome recorded |
| Phase 4 | NCT05537272 Comparator | Sep 2022 → Sep 2023 | urinary bladder disorder | University Hospital of Split | Unknown | No outcome recorded |
| Phase 4 | NCT05494567 Comparator | Nov 2021 → Aug 2022 | benign prostatic hyperplasia, overactive bladder | Mansoura University | Unknown | No outcome recorded |
| Phase 4 | NCT05818670 Comparator | Nov 2020 → Sep 2021 | benign prostatic hyperplasia | Mansoura University | Completed | No outcome recorded |
| Phase 4 | NCT04641507 Comparator | Jan 2020 → Mar 2022 | ureterolithiasis | Beni-Suef University | Unknown | No outcome recorded |
| Phase 4 | NCT05446493 Comparator | Apr 2019 → Mar 2021 | erectile dysfunction | Aswan University | Completed | No outcome recorded |
| Phase 4 | NCT03229889 Comparator | Jun 2017 → Mar 2022 | nephrolithiasis | University of California, Irvine | Completed | No outcome recorded |
| Phase 4 | NCT02891850 Comparator | Jan 2017 → Jan 2020 | pulmonary arterial hypertension | Bayer | Completed | Met primary |
| Phase 4 | NCT02554045 Comparator | Jan → Jun 2015 | obesity disorder, sexual disorder | University of Roma La Sapienza | Completed | No outcome recorded |
| Phase 4 | NCT02225548 Background | Sep 2014 → Dec 2018 | Parkinson disease, erectile dysfunction | University of South Florida | Unknown | No outcome recorded |
| Phase 4 | NCT01803828 Comparator | May 2014 → Jan 2019 | intrinsic cardiomyopathy, type 2 diabetes mellitus | University of Roma La Sapienza | Completed | No outcome recorded |
| Phase 4 | NCT01275339 Comparator | Dec 2012 → Apr 2017 | aortic valve stenosis | Washington University School of Medicine | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01364701 Comparator | Jun 2011 → Jun 2012 | erectile dysfunction | Rambam Health Care Campus | Unknown | No outcome recorded |
| Phase 4 | NCT01302444 Comparator | Mar 2011 → Mar 2012 | pulmonary arterial hypertension | Rhode Island Hospital | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01272388 Comparator | Jan → Apr 2011 | aortic valve stenosis | Washington University School of Medicine | Terminated | No outcome recorded |
| Phase 4 | NCT01130532 Comparator | Aug 2010 → Jan 2012 | erectile dysfunction | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 4 | NCT01305252 Comparator | Jul 2010 → Sep 2014 | pulmonary arterial hypertension | Stanford University | Completed | No outcome recorded |
| Phase 4 | NCT01067391 Comparator | Oct 2009 → Jul 2015 | hypotensive disorder, spinal cord injury | University of Manitoba | Completed | No outcome recorded |
| Phase 4 | NCT00617305 Background | Apr 2008 → Feb 2011 | pulmonary arterial hypertension | Gilead Sciences | Completed | Met primary |
| Phase 4 | NCT00547352 Comparator | Jun 2004 → Jun 2005 | erectile dysfunction | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 4 | NCT00663130 Comparator | Apr → Jul 2004 | erectile dysfunction | Bayer | Completed | No outcome recorded |
| Phase 4 | NCT00382135 Comparator | Nov 2003 → Dec 2005 | erectile dysfunction | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 4 | NCT00547092 Comparator | Oct 2003 → Nov 2004 | erectile dysfunction | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 4 | NCT00644956 Comparator | Jun → Nov 2003 | erectile dysfunction | Viatris Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00547599 Comparator | Apr 2003 → Jan 2004 | erectile dysfunction | Eli Lilly and Company | Completed | No outcome recorded |
| — | NCT07562282 Comparator | Dec 2025 → Jul 2026 overdue | ureterolithiasis, urolithiasis | Ain Shams University | Recruiting | No outcome recorded |
| — | NCT06213077 Comparator | Dec 2023 → Apr 2024 | erectile dysfunction | RHA Investments Ltd | Unknown | No outcome recorded |
| — | NCT06350773 Comparator | Jun 2023 → Dec 2025 overdue | pulmonary hypertension | Beni-Suef University | Active not recruiting | No outcome recorded |
| — | NCT05787769 Comparator | Mar 2023 → Jan 2025 | — | Mansoura University | Unknown | No outcome recorded |
| — | NCT06184334 Comparator | Sep → Dec 2022 | overactive bladder | Elsayed Abdelhalim Elsayed | Completed | No outcome recorded |
| — | NCT07844213 Comparator | Aug 2022 → Jul 2025 | congenital heart disease | China National Center for Cardiovascular Diseases | Completed | No outcome recorded |
| — | NCT05236634 Comparator | May 2022 → May 2024 | benign prostatic hyperplasia | Assiut University | Unknown | No outcome recorded |
| — | NCT05146674 Comparator | Jan → Dec 2022 | — | Mansoura University | Unknown | No outcome recorded |
| — | NCT05199727 Comparator | Sep 2021 → Mar 2022 | erectile dysfunction | Menoufia University | Unknown | No outcome recorded |
| — | NCT04623840 Comparator | Oct 2020 → Feb 2021 | erectile dysfunction | Cairo University | Unknown | No outcome recorded |
| — | NCT03834610 Comparator | Oct 2017 → Oct 2018 | erectile dysfunction | Aswan University Hospital | Completed | No outcome recorded |
| — | NCT04446598 Comparator | Mar 2017 → Nov 2018 | chronic prostatitis | Adrian Gaspar | Completed | No outcome recorded |
| — | NCT01661595 Comparator | Nov 2012 → Jun 2015 | — | The University of Texas Medical Branch, Galveston | Completed | No outcome recorded |
| — | NCT01743911 Comparator | Sep 2010 → Apr 2012 | hypertensive disorder | University of Campinas, Brazil | Completed | No outcome recorded |
| — | NCT00750308 Comparator | Dec 2006 → Jan 2009 | metabolic syndrome X | Vanderbilt University | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 54
| Date | Issuer | Release |
|---|---|---|
| 2026-06-08 | Opella Healthcare Group SAS, a Sanofi Company | Regulatory Opella expands global access to ED treatment with non-prescription approval of Cialis® in Japan. opella.com ↗
Opella announces the non-prescription approval of Cialis® in Japan, a significant milestone that facilitates access to erectile dysfunction (ED) treatment for millions of men1. |
| 2026-06-08 | Opella Healthcare Group SAS, a Sanofi Company | Regulatory Opella obtient l’autorisation de mise sur le marché sans ordonnance du Cialis® au Japon. opella.com ↗
Opella annonce le délistage du Cialis® au Japon, une étape importante qui facilite l'accès au traitement de la dysfonction érectile (DE) pour des millions d'hommes1. |
| 2025-02-11 | Lotus Pharmaceutical | Regulatory Lotus Announces TFDA Approval for Adcirca® (Tadalafil) for PAH Treatment lotuspharm.com ↗
Adcirca® (tadalafil) has been approved by the Taiwan Food and Drug Administration (TFDA) for treating pulmonary arterial hypertension (PAH). |
| 2025-01-21 | Sanofi | Regulatory Press Release: Opella reaches study milestone for Cialis sanofi.com ↗
Opella, Sanofi’s Consumer Healthcare business, announced that the US Food and Drug Administration (FDA) has lifted a clinical hold on its planned actual use trial (AUT) to support the switch of Cialis (tadalafil) from a prescription to an over-the-counter medicine. |
| 2024-03-22 | Janssen Research & Development, LLC | Regulatory U.S. FDA Approves OPSYNVI® (macitentan and tadalafil) as the First and Only Once-Daily Single-Tablet Combination Therapy for Patients with Pulmonary Arterial Hypertension (PAH) jnj.com ↗ |
| 2024-03-22 | Janssen Research & Development, LLC | Regulatory U.S. FDA Approves OPSYNVI® (macitentan and tadalafil) as the First and Only Once-Daily Single-Tablet Combination Therapy for Patients with Pulmonary Arterial Hypertension (PAH) jnj.com ↗ |
| 2023-06-26 | Janssen Research & Development, LLC | Regulatory Janssen Submits Marketing Authorisation Application to the European Medicines Agency (EMA) Seeking Approval of Single Tablet Combination Therapy (STCT) of Macitentan and Tadalafil for Treatment of Patients with Pulmonary Arterial Hypertension (PAH) jnj.com ↗ |
| 2023-06-07 | Zydus Lifesciences Limited | Regulatory Zydus receives final approval from the USFDA for Tadalafil Tablets USP, 20 mg zyduslife.com ↗
Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as “Zydus”) has received final approval from the United States Food and Drug Administration (USFDA) for Tadalafil Tablets USP, 20 mg (USRLD: Adcirca Tablets, 20 mg). |
| 2023-05-30 | Janssen Research & Development, LLC | Regulatory Janssen Submits New Drug Application to U.S. FDA Seeking Approval of Investigational Single Tablet Combination Therapy of Macitentan and Tadalafil for Treatment of Patients with Pulmonary Arterial Hypertension (PAH) jnj.com ↗ |
| 2023-05-30 | Janssen Research & Development, LLC | Regulatory Janssen Submits New Drug Application to U.S. FDA Seeking Approval of Investigational Single Tablet Combination Therapy of Macitentan and Tadalafil for Treatment of Patients with Pulmonary Arterial Hypertension (PAH) jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of an investigational single tablet combination therapy of macitentan 10mg and tadalafil 40mg (M/T STCT) for the long-term treatment of pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1) in adult patients with WHO functional class (FC) II-III.1 |
| 2023-03-06 | Janssen Research & Development, LLC | Results Late-Breaking Phase 3 A DUE Data Show Investigational Single Tablet Combination Therapy of Macitentan and Tadalafil Significantly Improves Pulmonary Hemodynamics versus Monotherapy in Patients with Pulmonary Arterial Hypertension (PAH) jnj.com ↗ |
| 2023-03-06 | Janssen Research & Development, LLC | Results Late-Breaking Phase 3 A DUE Data Show Investigational Single Tablet Combination Therapy of Macitentan and Tadalafil Significantly Improves Pulmonary Hemodynamics versus Monotherapy in Patients with Pulmonary Arterial Hypertension (PAH) jnj.com ↗
Late-Breaking Phase 3 A DUE Data Show Investigational Single Tablet Combination Therapy of Macitentan and Tadalafil Significantly Improves Pulmonary Hemodynamics versus Monotherapy in Patients with Pulmonary Arterial Hypertension (PAH) |
| 2022-05-30 | Sanofi | Regulatory Press Release: Update on Cialis® Rx-to-OTC Switch Actual Use Trial sanofi.com ↗
The U.S. Food and Drug Administration has informed Sanofi that its planned Actual Use Trial (AUT) to support the Rx-to-OTC switch for Cialis® (tadalafil) has been placed on clinical hold due to matters surrounding the protocol design. |
| 2021-10-15 | Janssen Research & Development, LLC | Regulatory OPSYNVI® (macitentan and tadalafil) Becomes the First and Only Health Canada-Approved Once Daily Fixed Dose Combination Treatment for Patients with Pulmonary Arterial Hypertension (PAH) jnj.com ↗ |
| 2021-10-15 | Janssen Research & Development, LLC | Regulatory OPSYNVI® (macitentan and tadalafil) Becomes the First and Only Health CanadaApproved Once Daily Fixed Dose Combination Treatment for Patients with Pulmonary Arterial Hypertension (PAH) jnj.com ↗ |
| 2021-02-23 | Veru Inc. | Regulatory Veru Submits New Drug Application for Proprietary TADFIN for BPH verupharma.com ↗
today announced that it has submitted a 505(b)(2) New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for TADFIN ™ (tadalafil 5mg and finasteride 5mg) capsules, a novel oral daily dosing combination formulation, for the treatment of benign prostatic hyperplasia (BPH). |
| 2021-02-15 | Upsher-Smith Laboratories | Regulatory Sawai Receives Approvals for Eight Generic Drugs with 20 Strengths upsher-smith.com ↗
Osaka, Japan – February 15, 2021 – Sawai Pharmaceutical Co., Ltd. (Sawai, Head office: Osaka, Japan, President: Kenzo Sawai) received approvals by the Ministry of Health, Labour and Welfare for eight generic drugs with 20 strengths. |
| 2020-12-31 | Glenmark Pharmaceuticals Ltd. India | Regulatory Glenmark Pharmaceuticals receives ANDA final approval for Tadalafil Tablets, 2.5 mg, 5 mg, 10 mg and 20 mg; and receives ANDA tentative approvals for Gabapentin Enacarbil Extended-Release Tablets, 300 mg and 600 mg and Apremilast Tablets, 10 mg, 20 mg and 30 mg glenmarkpharma.com ↗
Glenmark Pharmaceuticals Limited (Glenmark), a research-led global pharmaceutical company has received final approval by the United States Food & Drug Administration (U.S. FDA) for Tadalafil Tablets USP, 2.5 mg, 5 mg, 10 mg and 20 mg, the generic version of Cialis®1 Tablets, 2.5 mg, 5 mg, 10 mg and 20 mg, of Eli Lilly and Company. |
| 2020-02-20 | Upsher-Smith Laboratories | Regulatory Sawai Receives Approval for Tadalafil Tablets upsher-smith.com ↗
Sawai Pharmaceutical Co., Ltd. (Sawai, Head office: Osaka, Japan, President: Mitsuo Sawai) received approval by the Ministry of Health, Labour and Welfare (MHLW) for Tadalafil tablets (the branded product: Cialis®). |
| 2019-10-21 | Janssen Research & Development, LLC | Results New OPSUMIT® (macitentan) Data Show Initial Combination Therapy with Tadalafil Improved Hemodynamic Clinical and Functional Parameters in Patients with Pulmonary Arterial Hypertension jnj.com ↗
Patients with pulmonary arterial hypertension (PAH, WHO Group 1) taking this combination showed hemodynamic improvement, as well as improvements in functional parameters and risk profiles. |
| 2019-09-18 | Tavanta Therapeutics | Regulatory DRGT Announces the U.S. FDA IND Application Approval and First Dosing of a Clinical Trial to Evaluate the Bioavailability and Food Effect of Immediate-Release Formulation of Tadalafil (DRGT-99) tavanta.com ↗
the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application to initiate a randomized, single-dose crossover study |
| 2019-03-27 | Zydus Lifesciences Limited | Regulatory Zydus scores with the Day 1 launch of Tadalafil Tablets in the US zyduslife.com ↗
upon receiving the final approval from the US FDA for marketing the product in the strengths of 2.5 mg, 5 mg, 10 mg, and 20 mg. |
| 2019-03-27 | Lupin Limited | Regulatory Lupin receives FDA approval for Tadalafil Tablets USP lupin.com ↗ |
| 2019-02-07 | Lupin Limited | Regulatory Lupin receives FDA approval for Tadalafil Tablets USP, 20 mg lupin.com ↗
Pharma major Lupin announced that it has received approval for its Tadalafil Tablets USP, 20 mg from the United States Food and Drug Administration (FDA) to market a generic version of Eli Lilly and Company’s Adcirca Tablets, 20 mg. |
| 2019-01-14 | Veru Inc. | Results Veru Announces Successful Bioavailability and Bioequivalence Clinical Trial for Tadalafil and Finasteride Combination Tablet for Benign Prostatic Hyperplasia verupharma.com ↗
the clinical trial of the Company’s proprietary Tadalafil and Finasteride Combination tablet met the U.S. Food and Drug Administration’s (FDA) requirements for bioavailability and bioequivalence |
| 2018-12-19 | Lupin Limited | Regulatory Lupin receives tentative US FDA approval for Tadalafil Tablets USP, 20 mg lupin.com ↗
Mumbai, Baltimore: Pharma major Lupin announced that it has received tentative approval for its Tadalafil Tablets USP, 20 mg from the United States Food and Drug Administration (FDA) to market a generic version of Eli Lilly and Company’s (Lilly) Adcirca Tablets, 20 mg. |
| 2018-11-16 | XenoPort, Inc. | Regulatory Aquestive Therapeutics Receives Complete Response Letter from U.S. Food and Drug Administration (FDA) for Tadalafil Oral Film aquestive.com ↗
Aquestive Therapeutics, Inc. (NASDAQ: AQST) today announced it received a complete response letter (CRL) from the U.S. Food and Drug Administration ( FDA ) in regards to its New Drug Application (NDA) for tadalafil oral film (OF). |
| 2018-07-19 | Lupin Limited | Regulatory Lupin receives tentative FDA approval for generic Tadalafil Tablets USP, 2.5 mg, 5 mg, 10 mg, and 20 mg lupin.com ↗
it has received tentative approval for its Tadalafil Tablets USP, 2.5 mg, 5 mg, 10 mg, and 20 mg from the United States Food and Drug Administration (FDA) |
| 2018-05-02 | Tavanta Therapeutics | Results Best in Class Erectile Dysfunction Drug – DRGT announces dose escalation study results of its Super-Tadalafil DRGT-99 tavanta.com ↗
DRGT, a specialty pharmaceutical company with a proprietary formulation technology, announced the results of its successful dose escalation PK study for DRGT-99, an innovative formulation of tadalafil. |
| 2017-11-20 | United Therapeutics | Regulatory United Therapeutics Announces Additional Six Months Of Regulatory Exclusivity For Adcirca® unither.com ↗
A U.S. patent for Adcirca will expire November 21, 2017, and FDA's decision provides an additional six months of regulatory exclusivity running from this date, providing an additional six months before FDA can approve a generic version of Adcirca. |
| 2017-08-16 | Hanmi Pharmaceutical Company Limited | Results <보도자료> 한미약품 ‘구구탐스’ 3상 임상 결과, 국제학술지 등재 hanmi.co.kr ↗
연구 결과, 탐스로신 0.4mg 복합제 투여군에서 대조군 대비 IPSS(국제 전립선 증상 점수)가 약 27% 더 감소되었으며, 성기능 개선 효과는 비열등함을 보였다. |
| 2017-05-18 | Hanmi Pharmaceutical Company Limited | Results <보도자료> 한미약품 ‘구구탐스’ 3상 결과, 美 비뇨기과학회 구연발표 hanmi.co.kr ↗
발표 내용에 따르면, 탐스로신염산염 0.4mg 복합제 투여군에서 대조군 대비 IPSS(국제 전립선 증상 점수)가 약 27% 더 감소됐으며, 성기능 개선 효과는 비열등함을 확인했다. |
| 2016-12-26 | Hanmi Pharmaceutical Company Limited | Results <보도자료> 전립선비대증+발기부전 치료제 ‘구구탐스캡슐’ 출시 hanmi.co.kr ↗
전립선비대증 및 발기부전 동반 남성환자 510명을 총 3개군으로 나눠 1일 1회 12주간 투약한 결과, 구구탐스캡슐이 타다라필(Tadalafil) 5mg 단일군 대비 IPSS(국제 전립선 증상 점수)를 약 27% 더 감소시킨 것으로 나타났다. |
| 2016-10-21 | Hanmi Pharmaceutical Company Limited | Regulatory <보도자료> ‘전립선비대증+발기부전’ 복합제 ‘구구탐스’ 허가 hanmi.co.kr ↗
한미약품(대표이사 이관순, www.hanmi.co.kr)이 전립선비대증 치료 성분과 발기부전 치료 성분을 하나로 복합한 ‘구구탐스캡슐(성분 tamsulosin 0.4mg+tadalafil 5mg)’의 식약처 시판허가를 받았다고 21일 밝혔다. |
| 2016-09-27 | Hanmi Pharmaceutical Company Limited | Results <보도자료> ‘탐스로신·타다라필 복합제’ 3상 결과 세계성의학회 임상부문 최우수 연제상 선정 hanmi.co.kr ↗
발표 내용에 따르면, 탐스로신 0.4mg 복합제 투여군에서 대조군 대비 IPSS(국제 전립선 증상 점수)가 약 28% 더 감소되었으며, 성기능 개선 효과는 비열등함을 보였다. |
| 2015-10-02 | Gilead Sciences | Regulatory U.S. Food and Drug Administration Approves New Treatment Combination of Gilead’s Letairis® with Tadalafil for Pulmonary Arterial Hypertension (WHO Group 1) gilead.com ↗ |
| 2015-08-26 | Gilead Sciences | Results Results From the AMBITION Study of First-Line Treatment With Letairis and Tadalafil in Pulmonary Arterial Hypertension Published in The New England Journal of Medicine gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced detailed results from the AMBITION study (a randomized, double-blind, multicenter study of first-line combination therapy with AMB r I sentan and T adalafil in patients with pulmonary arterial hypertens ION ). |
| 2014-09-08 | GlaxoSmithKline | Results GSK announces first-line combination of ambrisentan and tadalafil reduces risk of clinical failure compared to monotherapy in pulmonary arterial hypertension outcomes study gsk.com ↗
The length of time before patients experienced clinical failure was significantly prolonged for those receiving first-line combination compared to monotherapy. |
| 2014-09-08 | Gilead Sciences | Results First-Line Combination of Ambrisentan and Tadalafil Reduces Risk of Clinical Failure Compared to Monotherapy in Pulmonary Arterial Hypertension Outcomes Study gilead.com ↗ |
| 2013-10-25 | Eli Lilly and Company | Regulatory FDA Approves Addition to CIALIS® (tadalafil) Product Label lilly.com ↗ |
| 2013-07-16 | Eli Lilly and Company | Results New Study Shows Men Taking Cialis® (tadalafil) Tablets Once Daily Returned to Normal Erectile Function after Incomplete Response to As-Needed PDE5 Inhibitor Therapy lilly.com ↗
In a pre-specified secondary measure, Cialis significantly improved erectile function scores versus placebo in those men who had an incomplete response to as-needed PDE5 treatment. |
| 2013-03-18 | Eli Lilly and Company | Results New Study of Cialis® (tadalafil) Tablets Co-administered with Finasteride Meets Primary Endpoint in Men with Lower Urinary Tract Symptoms of Benign Prostatic Hyperplasia lilly.com ↗
On a pre-specified secondary measure, Cialis/finasteride also improved erectile function scores versus placebo/finasteride in those men who had both LUTS/BPH and erectile dysfunction (ED) at baseline. |
| 2012-10-30 | Eli Lilly and Company | Regulatory European Commission approves Cialis® (tadalafil) tablets for the treatment of the signs and symptoms of benign prostatic hyperplasia lilly.com ↗
Eli Lilly and Company (NYSE: LLY) announced today that the European Commission has approved Cialis 5 mg for once daily use for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). |
| 2012-09-21 | Eli Lilly and Company | Regulatory Cialis® (tadalafil) Tablets Recommended for Approval for the Treatment of the Signs and Symptoms of Benign Prostatic Hyperplasia in the European Union lilly.com ↗
Eli Lilly and Company (NYSE: LLY) announced today it has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in the European Union (EU), recommending approval of Cialis 5 mg for once daily use for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). |
| 2012-02-07 | Eli Lilly and Company | Results New Study Evaluates Cialis® in parallel with Tamsulosin in Men with Signs and Symptoms Suggestive of Benign Prostatic Hyperplasia lilly.com ↗ |
| 2011-10-12 | Eli Lilly and Company | Results New Study Shows Cialis® Significantly Improved Study Endpoints in Men with Both Erectile Dysfunction and Signs and Symptoms of Benign Prostatic Hyperplasia lilly.com ↗
Eli Lilly and Company (NYSE: LLY) announced today that a pivotal Phase III study of Cialis® (tadalafil) tablets 5 mg for once daily use met its co-primary endpoints, significantly improving measures of both erectile dysfunction (ED) and signs and symptoms of benign prostatic hyperplasia (BPH) in men with both conditions. |
| 2011-10-06 | Eli Lilly and Company | Regulatory Cialis® for Once Daily Use Now FDA-Approved to Treat Men with Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) and Men with Both Erectile Dysfunction (ED) and Signs and Symptoms of BPH lilly.com ↗
The FDA also approved Cialis for once daily use for a separate indication for the treatment of the signs and symptoms of BPH. |
| 2009-06-09 | Eli Lilly and Company | Results Study Results Present Efficacy and Safety Findings from the PHIRST-1 Study of Patients with Pulmonary Arterial Hypertension Taking Tadalafil Tablets Once Daily lilly.com ↗
United Therapeutics Corporation (Nasdaq: UTHR) and Eli Lilly and Company (NYSE: LLY) today announced the results of a pivotal 16-week study showing that a once-daily dose of tadalafil was generally well tolerated, improved exercise capacity and improved time to clinical worsening in patients with pulmonary arterial hypertension (PAH)(1). |
| 2009-05-06 | Eli Lilly and Company | Results Study Reported Tadalafil Taken Once Daily Improved Erectile Function in Men with ED and Sexual Quality of Life in Couples lilly.com ↗
The average increase in SQoL scores from baseline to endpoint for men in the tadalafil group was 39.5 points, compared with 12.5 point increase in the placebo group. |
| 2008-01-08 | Eli Lilly and Company | Regulatory FDA Approves Cialis(R) (tadalafil) for Once Daily Use for the Treatment of Erectile Dysfunction lilly.com ↗
Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved Cialis(R) (tadalafil)(1) for once daily use (2.5 mg and 5 mg), an oral medication taken once per day to treat erectile dysfunction (ED). |
| 2006-04-06 | Eli Lilly and Company | Results New Data Show Cialis(R) (tadalafil) is Effective in Treating Erectile Dysfunction Caused by Traumatic Spinal Cord Injury lilly.com ↗
Further, 54 percent of SCI patients treated with Cialis reported "normal" erectile function at the end of the treatment phase, as measured by the IIEF EF (IIEF EF domain score greater than or equal to 26). |
| 2005-10-12 | Eli Lilly and Company | Results Lilly ICOS Announces Positive Results from Phase 2 Study of Tadalafil in Treating Symptoms of Benign Prostatic Hyperplasia lilly.com ↗
Lilly ICOS LLC, a joint venture between Eli Lilly and Company (NYSE:LLY) and ICOS Corporation (Nasdaq:ICOS), announced positive results from a double-blind, placebo-controlled clinical study of tadalafil in the treatment of lower urinary tract symptoms in men with benign prostatic hyperplasia (BPH). |
| 2005-05-23 | Eli Lilly and Company | Results Clinical Data Shows Lilly ICOS' Cialis(R) (tadalafil) Improves Erectile Function in ED Patients with Significant, Multiple Comorbid Conditions lilly.com ↗
Lilly ICOS LLC (NYSE: LLY and Nasdaq: ICOS) announced data today from an open-label clinical trial showing Cialis(R) (tadalafil)(1) improved erections in more than three- quarters of men who were suffering from erectile dysfunction (ED) and one or more comorbid conditions. |
| 2004-10-20 | Eli Lilly and Company | Results New Analysis Shows Lilly ICOS' Cialis (tadalafil) is Effective lilly.com ↗
These data show that men who have both BPH and ED and take Cialis experience improved erectile function. |
All press releases naming this drug 80 releases
Evidence & citations 23 cited values
Every value below carries the sentence it was read from. 250 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | tadalafil | “Patients were to be using a stable regimen of a PDE5-I (i.e., sildenafil, vardenafil, or tadalafil), as reported by the patient for the treatment of erectile dysfunction (ED)...” NCT01063855 ↗241“All patients will receive standard of care double oral background treatment consisting of one Phosphodiesterase type 5 inhibitor (i.e., tadalafil or sildenafil) and one...” NCT06317805 ↗ “Phosphodiesterase type 5 inhibitor group (PDE5+S), aside with the saline patients will be given orally 20 mg tablets of PDE5 Tadalafil once daily 2 hours prior to the...” NCT01564303 ↗ “Oral administration of a daily low-dose PDE5 inhibitor (e.g., Tadalafil 5 mg once daily) for a continuous duration of 6 months, aligning with standard clinical guidelines for...” NCT07707505 ↗ “Patients will be treated by tadalafil 5 mg tablet daily in addition to four Tadalafil 5 mg tablet 3 hours before intercourse on demand in addition to placebo injection.” NCT05787769 ↗ “This study evaluates the effect of 5 mg daily tadalafil therapy on serum levels of Endothelin-1 and E-selectin in diabetic male patients with erectile dysfunction.” NCT06962462 ↗ “Evaluation of safety and efficacy of Tamsulosin 0.4 mg plus Tadalafil 2.5 mg versus Tamsulosin 0.4 mg plus Tadalafil 5 mg in relieving stent-related symptoms.” NCT07562282 ↗ “Ro Sparks® is a combination sildenafil + tadalafil product administered on an on-demand basis.” NCT07231185 ↗ “study drug (Sildenafil or Tadalafil) administered orally in pill form with glass of water.” NCT04052269 ↗ “Group B: Forty patients with LUTS due to BPH will be given tadalafil 5 mg for 12 weeks.” NCT05236634 ↗ “Group C was treated with a combination of silodosin 8 mg and tadalafil 5 mg .” NCT06707181 ↗ |
| Known as | Adcirca | “Tadalafil (Adcirca®)” NCT03215966 ↗ |
| Known as | Adcirca (previously tadalafil lilly) | ChEMBL registry synonym — accepted as the source's own label CHEMBL779 ↗ |
| Known as | Chewtadzy | ChEMBL registry synonym — accepted as the source's own label CHEMBL779 ↗ |
| Known as | Cialis | “A Randomized, Open-Label, Crossover, Multicenter, Single Dose Comparator Study Evaluating Onset Of Penile Rigidity In Men With Erectile Dysfunction Who Are Treated With Viagra...” NCT00644956 ↗8“Can Tadalafil (Cialis)® Maintain Erectile Function In Patients Treated With External-beam Radiotherapy For Prostate Cancer?” NCT00215631 ↗ “Tadalafil (Cialis®; Eli Lilly) is widely prescribed for erectile dysfunction in men.” NCT02801032 ↗ “CIALIS (tadalafil) tablet 5 mg” NCT02352311 ↗ “Cialis (Tadalafil)” NCT00174486 ↗ |
| Known as | IC-351 | ChEMBL registry synonym — accepted as the source's own label CHEMBL779 ↗ |
| Known as | LY-450190 | ChEMBL registry synonym — accepted as the source's own label CHEMBL779 ↗ |
| Known as | NSC-750236 | ChEMBL registry synonym — accepted as the source's own label CHEMBL779 ↗ |
| Known as | NSC-759172 | ChEMBL registry synonym — accepted as the source's own label CHEMBL779 ↗ |
| Known as | TAD | “INTRODUCTION: Tadalafil (TAD) 5 mg coadministered with finasteride (FIN) 5 mg significantly improves lower urinary tract symptoms (LUTS) in men with benign prostatic...” PMID 25353053 ↗ Oct 20142“AIMS: To investigate the efficacy and safety of tadalafil (TAD) versus pentoxifylline (PTX) in the management of diabetic kidney disease (DKD).” PMID 38915115 ↗ Jun 2024 “tadalafil (TAD) is approved for both PRN and once-a-day (OaD) dosing for ED.” PMID 25455432 ↗ Dec 2014 |
| Known as | Tadalafil Citrate | “Drug: Tadalafil Citrate” NCT01291069 ↗ |
| Known as | Tadalafil component of entadfi | ChEMBL registry synonym — accepted as the source's own label CHEMBL779 ↗ |
| Known as | Tadalafil component of opsynvi | ChEMBL registry synonym — accepted as the source's own label CHEMBL779 ↗ |
| Known as | Tadalafil lilly | ChEMBL registry synonym — accepted as the source's own label CHEMBL779 ↗ |
| Known as | Tadalafil mylan | ChEMBL registry synonym — accepted as the source's own label CHEMBL779 ↗ |
| Known as | Tadalafilo | ChEMBL registry synonym — accepted as the source's own label CHEMBL779 ↗ |
| Known as | Tadliq | ChEMBL registry synonym — accepted as the source's own label CHEMBL779 ↗ |
| Known as | Talmanco (previously tadalafil generics) | ChEMBL registry synonym — accepted as the source's own label CHEMBL779 ↗ |
| Known as | Trans-tadalafil | ChEMBL registry synonym — accepted as the source's own label CHEMBL779 ↗ |
| Action | Inhibit | “Tadalafil, a phosphodiesterase type-5 inhibitor, increases cGMP, the final mediator in the nitric oxide pathway.” PMID 19470885 ↗ May 2009 |
| Modality | Small molecule | “a compound selectively inhibiting the breakdown of cGMP, the PDE5 inhibitor tadalafil.” NCT02801032 ↗ |
| Route | Oral | “taken by mouth” NCT00050609 ↗ |
| Target | PDE5A | “tadalafil target: PDE5A: rs12646525, rs3806808” NCT06520839 ↗ |