Last update 12 Dec 2024

Tadalafil

Last update 12 Dec 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

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

(6R,12aR)-2,3,6,7,12,12a-Hexahydro-2-methyl-6-(3,4-(methylenedioxy)phenyl) pyrazino(1',2':1,6)pyrido(3,4-b)indole-1,4-dione, (6R-trans)-6-(1,3-Benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-pyrazino(1',2':1,6)pyrido(3,4-b)indole-1,4-dione, Tadalafil (JAN/USP/INN)

+ [31]

Target

PDE5A

Mechanism

PDE5A inhibitors(Phosphodiesterase 5A inhibitors)

Therapeutic Areas

Respiratory DiseasesUrogenital DiseasesOther Diseases

Active Indication

Prostatic HyperplasiaFamilial Primary Pulmonary HypertensionPulmonary Arterial Hypertension+ [1]

Inactive Indication

Anemia, Sickle CellDiabetes MellitusDiabetic Gastroparesis+ [11]

Originator Organization

Eli Lilly & Co.

Active Organization

Nippon Shinyaku Co., Ltd.Eli Lilly Nederland BVB BETTER LLC

+ [6]

Inactive Organization

United Therapeutics Corp.

Lilly Asia Shanghai Representative Office

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

+ [1]

Drug Highest PhaseApproved

First Approval Date

AU (23 Oct 2002),

Erectile Dysfunction

RegulationPriority Review (CN), Orphan Drug (US)

Structure

Molecular FormulaC22H19N3O4

InChIKeyWOXKDUGGOYFFRN-IIBYNOLFSA-N

CAS Registry171596-29-5

496

Clinical Trials associated with Tadalafil

NCT04762082 / Not yet recruitingPhase 1

A Single Dose Randomized Five-Way Crossover Pharmacokinetics (PK) Study of Tadalafil Semi-Chewable (Gummy) Formulations in Healthy Volunteers

This is a randomized, open-label, single-dose, five-period crossover, relative bioavailability study to evaluate tadalafil gummy 10mg and tadalafil oral tablets 10mg in healthy volunteers

Start Date01 May 2025

Sponsor / Collaborator

Seattle Gummy Co.Startup

ChiCTR2400090488 / SuspendedPhase 1IIT

A prospective, single-center, randomized controlled clinical study on the treatment of type 2 diabetes mellitus erectile dysfunction (ED) with Qingzhi Capsules and Tadalafil, either in combination or as monotherapy.

Start Date07 Oct 2024

Sponsor / Collaborator-

CTRI/2024/08/072747 / Not yet recruitingPhase 2IIT

Comparative effectiveness of oral Sildenafil, oral Tadalafil, and intracavernosal papaverine for penile doppler ultrasonography in erectile dysfunction patients. - NIL

Start Date25 Sep 2024

Sponsor / Collaborator-

100 Clinical Results associated with Tadalafil

100 Translational Medicine associated with Tadalafil

100 Patents (Medical) associated with Tadalafil

2,580

Literatures (Medical) associated with Tadalafil

02 Dec 2024·MOLECULAR PHARMACEUTICS

Three Strikingly Different Crystal Habits of Tadalafil: Design, Characterization, Pharmaceutical Performance, and Computational Studies

Article

Author: Srivastava, Saurabh ; Vishwakarma, Arti ; Jahnavi, Avvaru Subha ; Dikundwar, Amol G. ; Bhale, Nagesh A. ; Shah, Saurabh ; Thomas, Sajesh P. ; Thakur, Tejender S.

The present study aims at improving the physicochemical properties of a widely used drug Tadalafil through crystal habit modification, without changing the polymorphic form. Three distinct types of crystal habits, namely, needle, plate, and block, were obtained under controlled crystallization protocols with optimized solvent compositions. Complete characterization of these three crystal habits was carried out using powder X-ray diffraction, differential scanning calorimetry, thermogravimetric analysis, and Fourier transform infrared spectroscopy. Morphological features were studied by optical and scanning electron microscopy. Evaluation of the pharmaceutical performance of different crystal habits reveals significant improvement in compressibility and flow properties for the block-shaped crystals in comparison to the needle- and plate-shaped crystals. Also, a more linear tablet compression behavior was noted for the plate and block morphologies of the API compared to their needle counterpart. In vitro dissolution studies showed distinct release profiles for the same API form with different crystal habits, i.e., needle > plate > block. Insights into crystal growth mechanism and the role of solvents in affording the observed crystal habits are presented based on molecular dynamics simulations of intermolecular interactions with crystal facets, in conjunction with the experimental crystal face indexing of the single crystals of different habits. These observations were further supported by interaction topology analysis and the electrostatic features on different crystal facets.

01 Dec 2024·CELLULAR AND MOLECULAR LIFE SCIENCES

Pharmacologically increasing cGMP improves proteostasis and reduces neuropathy in mouse models of CMT1

Article

Author: Moore, Seth M. ; VerPlank, Jordan J.S. ; Milne, G. Todd ; Marziali, Leandro N ; Feltri, Maria Laura ; VerPlank, Jordan J S ; Stevens, Mckayla ; Buys, Emmanuel S ; Buys, Emmanuel S. ; Milne, G Todd ; Marziali, Leandro N. ; Gawron, Joseph ; Moore, Seth M

Abstract:

Increasing cyclic GMP activates 26S proteasomes via phosphorylation by Protein Kinase G and stimulates the intracellular degradation of misfolded proteins. Therefore, agents that raise cGMP may be useful therapeutics against neurodegenerative diseases and other diseases in which protein degradation is reduced and misfolded proteins accumulate, including Charcot Marie Tooth 1A and 1B peripheral neuropathies, for which there are no treatments. Here we increased cGMP in the S63del mouse model of CMT1B by treating for three weeks with either the phosphodiesterase 5 inhibitor tadalafil, or the brain-penetrant soluble guanylyl cyclase stimulator CYR119. Both molecules activated proteasomes in the affected peripheral nerves, reduced polyubiquitinated proteins, and improved myelin thickness and nerve conduction. CYR119 increased cGMP more than tadalafil in the peripheral nerves of S63del mice and elicited greater biochemical and functional improvements. To determine whether raising cGMP could be beneficial in other neuropathies, we first showed that polyubiquitinated proteins and the disease-causing protein accumulate in the sciatic nerves of the C3 mouse model of CMT1A. Treatment of these mice with CYR119 reduced the levels of polyubiquitinated proteins and the disease-causing protein, presumably by increasing their degradation, and improved myelination, nerve conduction, and motor coordination. Thus, pharmacological agents that increase cGMP are promising treatments for CMT1 neuropathies and may be useful against other proteotoxic and neurodegenerative diseases.

01 Dec 2024·JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES

Methylated magnetic covalent organic framework for sample preparation and LC-MS/MS detection of 12 tadalafil analogs in dietary supplements

Article

Author: Lian, Jie ; Zhang, Feng ; Li, Meng ; Wang, Xiujuan ; Feng, Feng ; Xu, Xiuli

Tadalafil analogs are often illegally added to dietary supplements such as herbal beverages, protein powders and tablet foods. Due to the complexity of the matrices, effective extraction of tadalafil analogs is the key to achieve accurate quantification. Therefore, it is of great significance to establish a rapid and effective method for the analytical determination of tadalafil analogs in complex matrices. In this study, a novel methylated magnetic covalent organic framework, Fe₃O₄@TFPB-OT, was successfully synthesized under mild conditions. Fe₃O₄@TFPB-OT demonstrated robust adsorption capabilities, with capacities ranging from 52.4 to 90.9 mg/g for the tadalafil analogs. Several pre-enrichment parameters were optimized, including adsorbent dosage, extraction time, pH, shaking time, elution solvent, and desorption time. The applicability of Fe₃O₄@TFPB-OT was evaluated as effective adsorbents for the magnetic solid-phase extraction (MSPE) of 12 tadalafil analogs in dietary supplements. Combined with high-performance liquid chromatography-tandem mass spectrometry, the limits of detection (LODs) of this method ranged from 0.005 to 0.05 μg/L in liquid matrices and from 0.005 to 0.05 μg/kg in solid matrices, showing good sensitivity and recoveries ranged from 56.1 % to 90.9 %with relative standard deviations lower than 3.9 %, demonstrating good accuracy and precision. Additionally, the adsorbent retained its effectiveness after at least ten reuse cycles, indicating significant reusability. This study provides an effective method for the analysis and detection of tadalafil analogs in dietary supplements and has great potential for application.

195

News (Medical) associated with Tadalafil

03 Oct 2024

·www.globenewswire.com

Correction: Onconetix Announces Financing Through a $2.0 Million Private Placement of Series C Preferred Stock and Warrants, Establishes a $25 Million Equity Line of Credit

CINCINATTI, OH., Oct. 03, 2024 (GLOBE NEWSWIRE) -- In a release issued under the same headline earlier today by Onconetix, Inc. (Nasdaq: ONCO), please note that in the first paragraph of the release, the name of the financial advisor to Onconetix in the transaction had been corrected to Tungsten Advisors. The corrected release follows. Onconetix, Inc. (Nasdaq: ONCO) (“Onconetix” or “the Company”) (formerly Blue Water Biotech, Inc. (BWV)), a cancer diagnostics company focused on the research, development and commercialization of innovative solutions for oncology, today announced the signing and closing of a private placement of (i) 3,499 shares of the Company’s Series C Convertible Preferred Stock, $0.00001 par value (the “Series C Preferred Stock”), and (ii) warrants (the “Warrants”) to acquire up to an aggregate of 591,856 additional shares of the Company’s common stock, $0.00001 par value per share (the “Common Stock”), for aggregate gross proceeds of approximately $2.0 million. The Series C Preferred Stock are initially convertible into an aggregate of 776,590 shares of Common Stock, subject to certain anti-dilution adjustments. The Warrants will have an exercise price of $4.38 per share, subject to customary adjustments, and are exercisable beginning six months and one day after the issuance date (the “Initial Exercisability Date”) and expiring on the third anniversary of the Initial Exercisability Date. The Company has filed a Current Report on Form 8-K with the Securities and Exchange Commission on October 3, 2024, with additional details of the transaction. The Company agreed to seek stockholder approval for the issuance of all of the shares of Common Stock issuable upon conversion of the Series C Preferred Stock and exercise of the Warrants in accordance with the rules and regulations of the Nasdaq Stock Market. The Company intends to use the gross proceeds from the private placement for working capital and general corporate purposes. Additionally, on October 2, 2024, Onconetix entered into a Common Stock Purchase Agreement with an equity line institutional investor (the “Purchaser”), whereby the Company has the right, but not the obligation, to sell to the Purchaser, and, subject to limited exceptions, the Purchaser is obligated to purchase, up to $25 million of newly issued shares of the Company’s common stock. The Company’s right to commence sales of Common Stock to the Purchaser are subject to certain conditions, including that a registration statement covering the resale of such shares is declared effective by the SEC. Actual sales of shares of Common Stock to the Purchaser under the Purchase Agreement will depend on a variety of factors to be determined by the Company from time to time, including, among others, market conditions, the trading price of the Common Stock and determinations by the Company as to the appropriate sources of funding and the Company’s operations.“We are pleased to announce this private placement and the equity line of credit,” said Ralph Schiess, Interim CEO. “The Company expects to use the proceeds from the financing to fund operations and potential growth opportunities." Tungsten Advisors served as the financial advisor to Onconetix. About Onconetix, Inc. Onconetix is a commercial stage biotechnology company focused on the research, development and commercialization of innovative solutions for men’s health and oncology. Through our recent acquisition of Proteomedix, we own of Proclarix®, an in vitro diagnostic test for prostate cancer originally developed by Proteomedix and approved for sale in the European Union (“EU”) under the In Vitro Diagnostic Regulation (“IVDR”), which we anticipate will be marketed in the U.S. as a lab developed test (“LDT”) through our license agreement with Labcorp. We also own ENTADFI, an FDA-approved, once daily pill that combines finasteride and tadalafil for the treatment of benign prostatic hyperplasia (“BPH”), a disorder of the prostate. For more information, visit www.onconetix.com. Forward-Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements (including, without limitation, the receipt of stockholder approval, the intended use of proceeds from the offering, and the anticipated results of the Company’s sales and marketing efforts for its commercial stage products as described herein) are based on Onconetix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, market and other conditions; risks related to Onconetix’s ability to commercialize or monetize Proclarix and integrate the assets and commercial operations acquired in the share exchange with Proteomedix; risks related to the Company’s present need for capital to commercially launch Proclarix and have adequate working capital; risks related to Onconetix’s ability to attract, hire and retain skilled personnel necessary to commercialize and operate the Company’s commercial products; the failure to obtain and maintain the necessary regulatory approvals to market and commercialize Onconetix’s products; risks related to the Company’s ability to obtain and maintain intellectual property protection for its current products; whether the Company will be able to maintain compliance with Nasdaq’s applicable listing criteria and the effect of a delisting from Nasdaq on the market for the Company’s securities; and the Company’s reliance on third parties, including manufacturers and logistics companies. As with any commercial-stage pharmaceutical product or any product candidate under clinical development, there are significant risks in the development, regulatory approval and commercialization of biotechnology products. Onconetix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in Onconetix’s Annual Report on Form 10-K, filed with the SEC on April 11, 2024 and periodic reports filed with the SEC on or after the date thereof. All of Onconetix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.Contact Information: Onconetix, Inc.201 E. Fifth Street, Suite 1900Cincinnati, OH 45202Phone: (513) 620-4101 Investor Contact Information: Onconetix Investor RelationsEmail: investors@onconetix.com

AcquisitionLicense out/in

03 Oct 2024

·www.globenewswire.com

Onconetix Announces Financing Through a $2.0 Million Private Placement of Series C Preferred Stock and Warrants, Establishes a $25 Million Equity Line of Credit

CINCINATTI, Oh., Oct. 03, 2024 (GLOBE NEWSWIRE) -- Onconetix, Inc. (Nasdaq: ONCO) (“Onconetix” or “the Company”) (formerly Blue Water Biotech, Inc. (BWV)), a cancer diagnostics company focused on the research, development and commercialization of innovative solutions for oncology, today announced the signing and closing of a private placement of (i) 3,499 shares of the Company’s Series C Convertible Preferred Stock, $0.00001 par value (the “Series C Preferred Stock”), and (ii) warrants (the “Warrants”) to acquire up to an aggregate of 591,856 additional shares of the Company’s common stock, $0.00001 par value per share (the “Common Stock”), for aggregate gross proceeds of approximately $2.0 million. The Series C Preferred Stock are initially convertible into an aggregate of 776,590 shares of Common Stock, subject to certain anti-dilution adjustments. The Warrants will have an exercise price of $4.38 per share, subject to customary adjustments, and are exercisable beginning six months and one day after the issuance date (the “Initial Exercisability Date”) and expiring on the third anniversary of the Initial Exercisability Date. The Company has filed a Current Report on Form 8-K with the Securities and Exchange Commission on October 3, 2024, with additional details of the transaction. The Company agreed to seek stockholder approval for the issuance of all of the shares of Common Stock issuable upon conversion of the Series C Preferred Stock and exercise of the Warrants in accordance with the rules and regulations of the Nasdaq Stock Market. The Company intends to use the gross proceeds from the private placement for working capital and general corporate purposes. Tungsten Advisors (through its broker-dealer, Finalis Securities, LLC), served as financial advisor to Onconetix. Additionally, on October 2, 2024, Onconetix entered into a Common Stock Purchase Agreement with an equity line institutional investor (the “Purchaser”), whereby the Company has the right, but not the obligation, to sell to the Purchaser, and, subject to limited exceptions, the Purchaser is obligated to purchase, up to $25 million of newly issued shares of the Company’s common stock. The Company’s right to commence sales of Common Stock to the Purchaser are subject to certain conditions, including that a registration statement covering the resale of such shares is declared effective by the SEC. Actual sales of shares of Common Stock to the Purchaser under the Purchase Agreement will depend on a variety of factors to be determined by the Company from time to time, including, among others, market conditions, the trading price of the Common Stock and determinations by the Company as to the appropriate sources of funding and the Company’s operations. “We are pleased to announce this private placement and the equity line of credit,” said Ralph Schiess, Interim CEO. “The Company expects to use the proceeds from the financing to fund operations and potential growth opportunities." About Onconetix, Inc. Onconetix is a commercial stage biotechnology company focused on the research, development and commercialization of innovative solutions for men’s health and oncology. Through our recent acquisition of Proteomedix, we own of Proclarix®, an in vitro diagnostic test for prostate cancer originally developed by Proteomedix and approved for sale in the European Union (“EU”) under the In Vitro Diagnostic Regulation (“IVDR”), which we anticipate will be marketed in the U.S. as a lab developed test (“LDT”) through our license agreement with Labcorp. We also own ENTADFI, an FDA-approved, once daily pill that combines finasteride and tadalafil for the treatment of benign prostatic hyperplasia (“BPH”), a disorder of the prostate. For more information, visit www.onconetix.com. Forward-Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements (including, without limitation, the receipt of stockholder approval, the intended use of proceeds from the offering, and the anticipated results of the Company’s sales and marketing efforts for its commercial stage products as described herein) are based on Onconetix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, market and other conditions; risks related to Onconetix’s ability to commercialize or monetize Proclarix and integrate the assets and commercial operations acquired in the share exchange with Proteomedix; risks related to the Company’s present need for capital to commercially launch Proclarix and have adequate working capital; risks related to Onconetix’s ability to attract, hire and retain skilled personnel necessary to commercialize and operate the Company’s commercial products; the failure to obtain and maintain the necessary regulatory approvals to market and commercialize Onconetix’s products; risks related to the Company’s ability to obtain and maintain intellectual property protection for its current products; whether the Company will be able to maintain compliance with Nasdaq’s applicable listing criteria and the effect of a delisting from Nasdaq on the market for the Company’s securities; and the Company’s reliance on third parties, including manufacturers and logistics companies. As with any commercial-stage pharmaceutical product or any product candidate under clinical development, there are significant risks in the development, regulatory approval and commercialization of biotechnology products. Onconetix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in Onconetix’s Annual Report on Form 10-K, filed with the SEC on April 11, 2024 and periodic reports filed with the SEC on or after the date thereof. All of Onconetix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof. Contact Information: Onconetix, Inc.201 E. Fifth Street, Suite 1900Cincinnati, OH 45202Phone: (513) 620-4101 Investor Contact Information: Onconetix Investor RelationsEmail: investors@onconetix.com

Acquisition

01 Oct 2024

·pmlive.com

Johnson & Johnson’s Yuvanci granted EC approval to treat pulmonary arterial hypertension

Johnson & Johnson’s (J&J) Yuvanci (single tablet combination therapy [STCT] of macitentan and tadalafi) has been approved by the European Commission (EC) as a long-term treatment for pulmonary arterial hypertension (PAH). The STCT has been specifically authorised for use as a substitution therapy in adults of World Health Organization functional class two to three, who are already treated with the combination of macitentan and tadalafil as separate tablets. Affecting up to 55 per million adults, PAH is a progressive and life-threatening disease in which the blood vessels in the lungs thicken and narrow. This blocks the blood flow through the lungs, which raises blood pressure and results in a significant strain on the heart. Macitentan works by dilating the narrow blood vessels between the right side of the heart and the lungs, making it easier for the heart to pump blood through them, as well as reducing and preventing the overgrowth of cells in the walls of these vessels; while tadalafil is designed to relax the blood vessels in the lungs, widening them to decrease the pulmonary blood pressure to the heart and improve its function. Until now, no single tablet that targets two or more PAH-specific pathways has been available for PAH patients in Europe. The EC’s decision follows a recent recommendation from the European Medicines Agency’s human medicines committee and was based on positive results from the late-stage A DUE study, in which Yuvanci demonstrated 29% and 28% reductions in pulmonary vascular resistance compared to macitentan and tadalafil monotherapies, respectively. Tamara Werner-Kiechle, EMEA therapeutic area lead neuroscience and cardiopulmonary, J&J Innovative Medicine, said: “People living with PAH face complex treatment regimens, with many having to take multiple pills per day. This can deeply impact their daily lives as they might struggle to maintain adherence to their treatment regimen. “This approval addresses a significant unmet need for the PAH community and we are delighted to bring a new and innovative treatment option to adults living with PAH that follows the European Society of Cardiology/European Respiratory Society guidelines, which recommend initial double and timely escalation to triple combination therapy.”

Drug ApprovalClinical Result

100 Deals associated with Tadalafil

External Link

KEGG	Wiki	ATC	Drug Bank
D02008	Tadalafil	G04BE08	DB00820

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Prostatic Hyperplasia	US	Eli Lilly & Co.	06 Oct 2011
Familial Primary Pulmonary Hypertension	EU	Eli Lilly Nederland BV	01 Oct 2008
Familial Primary Pulmonary Hypertension	IS	Eli Lilly Nederland BV	01 Oct 2008
Familial Primary Pulmonary Hypertension	LI	Eli Lilly Nederland BV	01 Oct 2008
Familial Primary Pulmonary Hypertension	NO	Eli Lilly Nederland BV	01 Oct 2008
Pulmonary Arterial Hypertension	EU	Eli Lilly Nederland BV	01 Oct 2008
Pulmonary Arterial Hypertension	IS	Eli Lilly Nederland BV	01 Oct 2008
Pulmonary Arterial Hypertension	LI	Eli Lilly Nederland BV	01 Oct 2008
Pulmonary Arterial Hypertension	NO	Eli Lilly Nederland BV	01 Oct 2008
Erectile Dysfunction	AU	Eli Lilly Australia Pty Ltd.	23 Oct 2002

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Muscular Dystrophy, Duchenne	Phase 3	US	Eli Lilly & Co.	01 Sep 2013
Muscular Dystrophy, Duchenne	Phase 3	JP	Eli Lilly & Co.	01 Sep 2013
Muscular Dystrophy, Duchenne	Phase 3	AR	Eli Lilly & Co.	01 Sep 2013
Muscular Dystrophy, Duchenne	Phase 3	BE	Eli Lilly & Co.	01 Sep 2013
Muscular Dystrophy, Duchenne	Phase 3	CA	Eli Lilly & Co.	01 Sep 2013
Muscular Dystrophy, Duchenne	Phase 3	FR	Eli Lilly & Co.	01 Sep 2013
Muscular Dystrophy, Duchenne	Phase 3	DE	Eli Lilly & Co.	01 Sep 2013
Muscular Dystrophy, Duchenne	Phase 3	IT	Eli Lilly & Co.	01 Sep 2013
Muscular Dystrophy, Duchenne	Phase 3	NL	Eli Lilly & Co.	01 Sep 2013
Muscular Dystrophy, Duchenne	Phase 3	PR	Eli Lilly & Co.	01 Sep 2013

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


FDA_CDER Manual	Not Applicable	Prostatic Hyperplasia	696	Placebo and finasteride 5 mg	zshyrijeir(ituzoxryjh) = vyduebkqrk njzneixibo (jggjtrpcze ) View more	Positive	28 Jun 2024
				Tadalafil 5 mg and finasteride 5 mg	zshyrijeir(ituzoxryjh) = gzirghtpfc njzneixibo (jggjtrpcze ) View more
FDA_CDER Manual	Not Applicable	Prostatic Hyperplasia \| Erectile Dysfunction	606	Placebo	etoenbfreo(yratitieds) = wknjorches ucorfmjpeb (sfvebcftcu ) View more	Positive	28 Jun 2024
				Tadalafil 5 mg	etoenbfreo(yratitieds) = ivkuhgtibg ucorfmjpeb (sfvebcftcu ) View more
FDA_CDER Manual	Not Applicable	Prostatic Hyperplasia	-	Placebo (Study J)	feocrkakke(dyjdpmfuos) = bxuehqpayt hvgpzioekf (qrdurhlbgm )	Positive	28 Jun 2024
				Tadalafil 5 mg (Study J)	feocrkakke(dyjdpmfuos) = ufljlsazst hvgpzioekf (qrdurhlbgm )
FDA_CDER Manual	Not Applicable	Erectile Dysfunction	1,112	Placebo (Outside the US)	rpjgtiwgsx(mieyxbbklc) = zkpatunhwf mwrgrpxutg (ogwjxtsfud, 0.7) View more	Positive	28 Jun 2024
				Tadalafil 5 mg (Outside the US)	rpjgtiwgsx(mieyxbbklc) = gefferuohx mwrgrpxutg (ogwjxtsfud, 4.0) View more
FDA_CDER Manual	Not Applicable	Erectile Dysfunction	402	Placebo (Study A + US Trials)	vetdmsdrsi(bondxmnumd) = jnykxojmqw jbsgbmroaz (hpgsxgkjva ) View more	Positive	28 Jun 2024
				Tadalafil 20 mg (Study A + US Trials)	vetdmsdrsi(bondxmnumd) = hgwfaflotv jbsgbmroaz (hpgsxgkjva ) View more
NCT05487755 (Pubmed) Manual	Phase 3	Diabetic Nephropathies Adjuvant	90	Tadalafil 20 mg	oretdreulc(fjawpvktth) = sjqkqjwcuq piguxwrlpt (hbllojjsyj )	Positive	24 Jun 2024
				Pentoxifylline 400 mg	oretdreulc(fjawpvktth) = pynagrsiho piguxwrlpt (hbllojjsyj )
ATS2024	Not Applicable	Pulmonary Arterial Hypertension \| Chronic Disease	-	Tadalafil 40mg	rlhufdugin(hihetlddfc) = failure of the PVR to decrease is always abnormal and implies pulmonary vascular disease ypyciywmax (otcypxidnf ) View more	-	19 May 2024
NEWS Manual	Not Applicable	Erectile Dysfunction	635	他达拉非5mg每日一次	kysuwsbkxg(keyqcwvucb) = yyczxlpckg adwsdgggwf (opjuzvmzfd ) View more	Positive	13 Mar 2024
MDA2024	Not Applicable	Muscular Dystrophy, Duchenne	-	Tadalafil 0.6 mg/Kg	djxjxgnyua(eabbiyzqvf) = iokcrncvan wvixklfqoh (dqkhgoacla, 0.8)	-	03 Mar 2024
				tadalafil (Unaffected controls)	djxjxgnyua(eabbiyzqvf) = yvzlrftuij wvixklfqoh (dqkhgoacla, 1.7)
NCT05142254 (Pin Trial, ASH2023)	Phase 2	Priapism	64	Tadalafil 5mg/day and Hydroxyurea 20mg/kg/day	ujykwlxokr(bdbmujrfub) = rbooyrfpgm kpbmjaesrf (iymcbmrawp )	Negative	10 Dec 2023
				Hydroxyurea 20mg/kg/day and Placebo	ujykwlxokr(bdbmujrfub) = llnrrzrrew kpbmjaesrf (iymcbmrawp )

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