[Translation] A single-center, open-label, randomized, single-dose, two-period, double-crossover bioequivalence study of vardenafil hydrochloride tablets in healthy subjects under fasting and fed conditions.

主要研究目的：健康受试者空腹和餐后状态下，单次口服江西汇仁药业股份有限公司生产的受试制剂盐酸伐地那非片（规格：20mg）或Bayer AG生产的参比制剂盐酸伐地那非片（商品名：Levitra®；规格：20mg），分别考察空腹和餐后状态下受试制剂与参比制剂在健康受试者体内的药代动力学参数，评价两制剂的生物等效性。次要研究目的：考察受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

Main research purpose: Healthy subjects were given a single oral dose of the test preparation vardenafil hydrochloride tablets (specification: 20 mg) produced by Jiangxi Huiren Pharmaceutical Co., Ltd. or the reference preparation vardenafil hydrochloride tablets (trade name: Levitra®; specification: 20 mg) produced by Bayer AG in the fasting and postprandial states, and the pharmacokinetic parameters of the test preparation and the reference preparation in the healthy subjects were investigated respectively, and the bioequivalence of the two preparations was evaluated. Secondary research purpose: To investigate the safety of the test preparation and the reference preparation in healthy subjects.

Start Date07 Mar 2024

Sponsor / Collaborator

Jiangxi Huiren Pharmaceutical Co., Ltd.

CTR20234025 / CompletedNot Applicable

盐酸伐地那非片在中国健康受试者空腹和餐后状态下的单中心、随机、开放、两制剂、四周期、两序列、单次给药、完全重复交叉生物等效性研究

[Translation] A single-center, randomized, open-label, two-dose, four-period, two-sequence, single-dose, completely repeated crossover bioequivalence study of vardenafil hydrochloride tablets in Chinese healthy subjects under fasting and fed conditions

主要目的：以伐地那非的主要药代动力学参数（AUC和Cmax）为生物等效性评价指标，在中国健康受试者空腹和餐后状态下评估受试制剂（杭州民生药物研究院有限公司委托江苏万高药业股份有限公司生产的盐酸伐地那非片，规格：20mg）和参比制剂（Bayer AG持证的盐酸伐地那非片，规格：20mg；商品名：Levitra®）的生物等效性。次要目的：观察空腹和餐后状态下受试制剂和参比制剂的安全性。

[Translation]

Primary objective: To evaluate the bioequivalence of the test preparation (vardenafil hydrochloride tablets, specification: 20 mg, produced by Jiangsu Wangao Pharmaceutical Co., Ltd., commissioned by Hangzhou Minsheng Pharmaceutical Research Institute Co., Ltd.) and the reference preparation (vardenafil hydrochloride tablets certified by Bayer AG, specification: 20 mg; trade name: Levitra®) in Chinese healthy subjects under fasting and fed conditions, using the main pharmacokinetic parameters (AUC and Cmax) of vardenafil as bioequivalence evaluation indicators. Secondary objective: To observe the safety of the test preparation and the reference preparation under fasting and fed conditions.

Start Date08 Dec 2023

Sponsor / Collaborator

Hangzhou Minsheng Pharmaceutical Research Institute Co., Ltd.

CTR20232492 / CompletedNot Applicable

盐酸伐地那非片在健康受试者中单中心、开放、随机、单剂量、双周期、双交叉空腹和餐后状态下的生物等效性试验

主要目的比较空腹及餐后给药条件下，山东华铂凯盛生物科技有限公司提供的盐酸伐地那非片（20 mg）与Bayer AG持证的盐酸伐地那非片（20 mg，商品名：Levitra®）在健康成年男性人群中吸收程度和速度的差异，评价其生物等效性。次要目的评价空腹及餐后给药条件下，山东华铂凯盛生物科技有限公司提供的盐酸伐地那非片（20 mg）与Bayer AG持证的盐酸伐地那非片（20 mg，商品名：Levitra®）的安全性。

[Translation]

Main purpose To compare the differences in the extent and rate of absorption of vardenafil hydrochloride tablets (20 mg) provided by Shandong Huabo Kaisheng Biotechnology Co., Ltd. and vardenafil hydrochloride tablets (20 mg, trade name: Levitra®) approved by Bayer AG in healthy adult males under fasting and postprandial administration conditions, and to evaluate their bioequivalence. Secondary purpose To evaluate the safety of vardenafil hydrochloride tablets (20 mg) provided by Shandong Huabo Kaisheng Biotechnology Co., Ltd. and vardenafil hydrochloride tablets (20 mg, trade name: Levitra®) approved by Bayer AG under fasting and postprandial administration conditions.

Start Date04 Oct 2023

Sponsor / Collaborator

Shandong Hubble Kisen Biological Technology Co Ltd

100 Clinical Results associated with Vardenafil Hydrochloride

100 Translational Medicine associated with Vardenafil Hydrochloride

100 Patents (Medical) associated with Vardenafil Hydrochloride

1,083

Literatures (Medical) associated with Vardenafil Hydrochloride

01 Feb 2024·The Journal of biological chemistry

Probing the mechanism by which the retinal G protein transducin activates its biological effector PDE6

Article

Author: Aplin, Cody ; Cerione, Richard A

Phototransduction in retinal rods occurs when the G protein-coupled photoreceptor rhodopsin triggers the activation of phosphodiesterase 6 (PDE6) by GTP-bound alpha subunits of the G protein transducin (Gα_T). Recently, we presented a cryo-EM structure for a complex between two GTP-bound recombinant Gα_T subunits and native PDE6, that included a bivalent antibody bound to the C-terminal ends of Gα_T and the inhibitor vardenafil occupying the active sites on the PDEα and PDEβ subunits. We proposed Gα_T-activated PDE6 by inducing a striking reorientation of the PDEγ subunits away from the catalytic sites. However, questions remained including whether in the absence of the antibody Gα_T binds to PDE6 in a similar manner as observed when the antibody is present, does Gα_T activate PDE6 by enabling the substrate cGMP to access the catalytic sites, and how does the lipid membrane enhance PDE6 activation? Here, we demonstrate that 2:1 Gα_T-PDE6 complexes form with either recombinant or retinal Gα_T in the absence of the Gα_T antibody. We show that Gα_T binding is not necessary for cGMP nor competitive inhibitors to access the active sites; instead, occupancy of the substrate binding sites enables Gα_T to bind and reposition the PDE6γ subunits to promote catalytic activity. Moreover, we demonstrate by reconstituting Gα_T-stimulated PDE6 activity in lipid bilayer nanodiscs that the membrane-induced enhancement results from an increase in the apparent binding affinity of Gα_T for PDE6. These findings provide new insights into how the retinal G protein stimulates rapid catalytic turnover by PDE6 required for dim light vision.

01 Jan 2024·Pharmacoepidemiology and drug safety

Oral phosphodiesterase type 5 inhibitors and priapism: A VigiBase analysis

Article

Author: Lui, Jason L ; Breyer, Benjamin N ; Shaw, Nathan M ; Nabavizadeh, Behnam ; Hakam, Nizar ; Abbasi, Behzad

Abstract:

Purpose:

To explore the differences of priapism events among a diverse cohort taking erectogenic medicines (i.e., phosphodiesterase type 5 inhibitors [PDE5i] and intracavernousal drugs).

Methods:

We queried the World Health Organization global database of individual case safety reports (VigiBase) for records of the adverse drug reactions (ADR) with sildenafil, tadalafil, avanafil, vardenafil, papaverine, and alprostadil. Disproportionality analyses (case/non‐case approach) were performed to assess the reporting odds ratio (ROR) of priapism reporting in PDE5i consumers compared to intracavernousal drug recipients.

Results:

From a total of 133 819 ADR events for erectogenic medications, 632 were priapism (PDE5is: n = 550, 0.41%; intracavernousal drugs: n = 82, 9.92%). Priapism disproportionality signals from intracavernousal drugs were 25 times stronger than PDE5is (ROR = 34.7; confidence interval [CI] 95%: 27.12–43.94 vs. ROR = 1.38; 95% CI: 1.24–1.54). For all PDE5i agents, the 12–17 years age group had the highest ROR (9.49, 95% CI: 3.76–19.93) followed by 2–11 years (4.31, 95% CI: 1.57–9.4). Disproportionality signals for consumers under 18 for both all PDE5is as a whole (ROR = 4.57, 95% CI: 2.48–7.73) and sildenafil (ROR = 4.89, 95% CI: 2.51–8.62) were stronger than individuals 18 or older (ROR = 1.06, 95% CI: 0.93–1.21 and ROR = 1.08, 95% CI: 0.91–1.26, respectively).

Conclusions:

PDE5i use shows disproportionate priapism signals which are higher in young patients.

02 Dec 2023·Food additives & contaminants. Part A, Chemistry, analysis, control, exposure & risk assessment

Analytical methods for the detection and characterization of unapproved phosphodiesterase type 5 inhibitors (PDE-5i) used in adulteration of dietary supplements- a review

Review

Author: Kee, Chee-Leong ; Ge, Xiaowei ; Malet-Martino, Myriam ; Low, Min-Yong ; Gilard, Véronique

This article is an up-to-date review of 112 unapproved phosphodiesterase type 5 inhibitors (PDE-5i) found as adulterants in sexual enhancement dietary supplements and other products from 2003 to July 2023. Seventy-five of these unapproved PDE-5i are analogues of sildenafil (67%), followed by 26 analogues of tadalafil (23%), 9 analogues of vardenafil (8%) and 2 other type of compounds (2%). The products have been formulated in various packaging, primarily in capsule, tablet, and powder forms. Common screening techniques allowing detection of such analogues include high performance or ultra-high performance liquid chromatography in tandem with ultra-violet detector (HPLC-UV or UPLC-UV) (50%) and thin-layer chromatography in tandem with ultra-violet detection (TLC-UV) (7%). Screening by mass spectrometry (MS) is relatively less common with the use of single-, triple-quadrupole or time-of-flight (TOF) mass spectrometers (9%). Meanwhile, the combined detection by UV-MS has been recorded at 10% usage. Screening by proton nuclear magnetic resonance spectroscopy (NMR) (11%) has also been applied. For compound characterization, i.e. structural elucidation, NMR spectroscopy has been preferred (100 out of 112 compounds), followed by high-resolution mass spectrometry (HRMS) (74 out of 112 compounds) and Fourier-transform infrared spectroscopy (FTIR) (44 out of 112 compounds). Over the past two decades, analytical technology has been evolving with enhanced sensitivity and resolution. Despite this, structural elucidation of the new emerging analogues in adulterated dietary supplements remains a challenge, especially when the analogues involve complex structural modification. Therefore, the above-mentioned techniques may not be adequate to characterize the analogues. Additional work involving chiroptical methods, two-dimensional (2D) NMR experiments and X-ray crystallography are likely to be required in the future.

News (Medical) associated with Vardenafil Hydrochloride

20 Jun 2024

·www.prnewswire.com

Palatin Announces the Initiation of a Phase 2 Clinical Study of Bremelanotide Co-Administered with a PDE5i for the Treatment of Erectile Dysfunction (ED)

In ED patients that do not respond to PDE5i monotherapy ~30-40% of ED patients do not respond to PDE5i treatment Data from this Phase 2 clinical study is expected by end of calendar year 2024 Published clinical data and mechanisms of action support clinical study of bremelanotide in combination with a PDE5i Phase 3 clinical study with new co-formulated bremelanotide plus a PDE5i in ED patients that do not respond to PDE5i monotherapy expected to start in the 1st half of calendar year 2025 CRANBURY, N.J., June 20, 2024 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor system, announced the initiation of a Phase 2 clinical study of bremelanotide (BMT), a melanocortin 4 receptor (MC4R), co-administered with a phosphodiesterase 5 inhibitor (PDE5i), for the treatment of erectile dysfunction (ED) in patients that do not respond to PDE5i monotherapy. Topline data from the Phase 2 clinical study is expected by the end of calendar year 2024. "Approximately 30-40% of ED patients exhibit little or no response to PDE5i monotherapy, such as Viagra, Cialis, and Levitra," said Carl Spana, Ph.D., President and Chief Executive Officer of Palatin. "These PDE5i monotherapy drugs account for over $4 billion of annual sales, yet PDE5i monotherapy does not work for a significant portion of ED patients. This represents a substantial unmet medical need for more effective ED treatments. Based on our clinical data and mechanisms of action research, we believe that BMT combined with a PDE5i is synergistic and will be a clinically meaningful ED treatment for non-responders to current PDE5i monotherapy." The Phase 2 clinical trial is designed to enroll approximately 50 patients to be treated with BMT co-administered with a PDE5i in an open-label, dose escalation study treating men with ED who are considered non-responders to PDE5i monotherapy treatment. The clinical study is being conducted under an investigator-sponsored Investigational New Drug (IND) and has Food and Drug Administration (FDA) clearance and Institutional Review Board (IRB) approval. The study's primary objective is to assess the safety and efficacy of BMT co-administered with a PDE5i for the treatment of ED in males who have not adequately responded to prior PDE5i monotherapy. "ED has become more prominent over the last several decades, especially in younger adults, and represents a mounting health concern causing a significant effect on men's quality of life," said Jed Kaminetsky, MD, FACS, Urologist, Director of Research, Integrated Medical Professionals, a Division of Solaris Health and the clinical study lead investigator. "Many patients in my practice are seeking better results from their ED treatment. Men with more severe ED do not respond as well using a PDE5i and have limited non-surgical options. I have used bremelanotide in my practice for men with ED. I believe the combination of bremelanotide with a PDE5i could potentially be an effective treatment option for the PDE5i non-responders suffering from ED." Palatin has conducted multiple clinical studies of monotherapy BMT and combination therapy BMT plus a PDE5i in men with ED and observed statistically significant and clinically meaningful effects on improving erectile function. In addition, sub-cutaneous bremelanotide 1.75 mg (Vyleesi®) is approved by the FDA for the treatment of hypoactive sexual desire disorder (HSDD) in pre-menopausal women and has demonstrated an increase in sexual desire and decrease in distress associated with low desire. Palatin has developed a new co-formulation of bremelanotide and a PDE5i which can be administered as a single injection. An IND for this novel co-formulation for the treatment of ED is expected to be filed with the FDA later this calendar year and a potential Phase 3 clinical study in ED patients who do not respond to PDE5i monotherapy is expected to start in the first half of calendar year 2025. About Erectile Dysfunction (ED) Erectile dysfunction is the consistent inability to attain and maintain an erection sufficient for sexual intercourse and affects an estimated 30 million men in the United States, according to the Centers for Disease Control and Prevention. Approximately 30-40% of men are non-responsive to standard therapies with phosphodiesterase-5 inhibitors (PDE5i) such as sildenafil (Viagra®), vardenafil (Levitra®) and tadalafil (Cialis®). There are limited therapeutic options for ED patients non-responsive to PDE5i therapy, including alprostadil for direct penis injection or urethral suppositories, surgical penile implants and various devices. About Palatin Palatin is a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor systems, with targeted, receptor-specific product candidates for the treatment of diseases with significant unmet medical need and commercial potential. Palatin's strategy is to develop products and then form marketing collaborations with industry leaders to maximize their commercial potential. To learn more about Palatin, please visit us on and follow us on Twitter at @PalatinTech. Forward-looking Statements Statements in this press release that are not historical facts, including statements about future expectations of Palatin Technologies, Inc., such as statements about Palatin products in development, clinical trial results, potential actions by regulatory agencies including the FDA, regulatory plans, development programs, proposed indications for product candidates, and market potential for product candidates are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995. Palatin intends that such forward-looking statements be subject to the safe harbors created thereby. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause Palatin's actual results to be materially different from its historical results or from any results expressed or implied by such forward-looking statements. Palatin's actual results may differ materially from those discussed in the forward-looking statements for reasons including, but not limited to, results of clinical trials, regulatory actions by the FDA and other regulatory agencies and the need for regulatory approvals, Palatin's ability to fund development of its technology and establish and successfully complete clinical trials, the length of time and cost required to complete clinical trials and submit applications for regulatory approvals, products developed by competing pharmaceutical, biopharmaceutical and biotechnology companies, commercial acceptance of Palatin's products, and other factors discussed in Palatin's periodic filings with the Securities and Exchange Commission. Palatin is not responsible for updating events that occur after the date of this press release. Palatin Technologies® is a registered trademark of Palatin Technologies, Inc. SOURCE Palatin Technologies, Inc.

Phase 2Phase 3Oligonucleotide

06 May 2024

·www.biospace.com

Can-Fite Received Notice of Allowance from the European Patent Office for the Treatment of Erectile Dysfunction with CF602

Patent has already been issued in other major markets including the U.S. PETACH TIKVA, Israel--(BUSINESS WIRE)-- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today announced it received a Notice of Allowance from the European Patent Office for its patent application titled “An A3 Adenosine Receptor Ligands For Use in Treatment of a Sexual Dysfunction”. This invention addresses the use of the CF602 drug candidate as an oral or topical drug for patients such as diabetics, who suffer from erectile dysfunction, and cannot use the current drugs on the market. While oral phosphodiesterase type 5 (PDE5) inhibitors are the current standard of care for erectile dysfunction (ED), with brands including Viagra, Cialis, Levitra, and Stendra, an estimated 30% to 35% of ED patients are non-responders, and these drugs can be contraindicated for people living with diabetes. Can-Fite recently published an article in Andrologia, suggesting that CF602 could potentially offer an alternative to the current drugs on market. A full erectile recovery was achieved following a single dose of CF602 with restored muscle collagen ratio and endothelial cell function. Can-Fite’s CF602, an allosteric modulator of the A3 adenosine receptor (A3AR), applied topically or orally in a diabetic rat model, resulted in increased arterial blood flow and significant dose-dependent improvements in intracavernosal pressure (ICM), smooth muscle/collagen ratio, vascular endothelial growth factor and endothelial nitric oxide synthase. treatment to PDE5 inhibitors, particularly to PDE5 non-responders and diabetics. “This additional European patent for erectile dysfunction adds to our growing IP estate for this high-value indication of the CF602 drug candidate. We believe our strong and broad IP, together with the pre-clinical positive data position it as a promising candidate for further development for the treatment of sexual dysfunction,” stated Motti Farbstein, Can-Fite CEO. The Erectile Dysfunction market is expected to reach approximately $6.6 billion by 2030, according to Market Research Future. About Namodenoson Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is currently being evaluated in a pivotal Phase III trial for advanced liver cancer, a Phase IIb trial for the treatment of steatotic liver disease (SLD), and the Company is planning a Phase IIa study in pancreatic cancer. A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential expression may be one of the important factors that accounts for the excellent safety pro the drug. About Can-Fite BioPharma Ltd. Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF) is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion dollar markets in the treatment of cancer, liver, and inflammatory disease. The Company's lead drug candidate, Piclidenoson recently reported topline results in a Phase III trial for psoriasis and is expected to commence a pivotal Phase III. Can-Fite's cancer and liver drug, Namodenoson, is being evaluated in a Phase IIb trial for the treatment metabolic dysfunction-associated steatohepatitis (MASH), a Phase III pivotal trial for hepatocellular carcinoma (HCC), and the Company is planning a Phase IIa study in pancreatic cancer. Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. CF602, the Company's third drug candidate, has shown efficacy in the treatment of erectile dysfunction. These drugs have an excellent safety pro experience in over 1,600 patients in clinical studies to date. For more information please visit: . Forward-Looking Statements This press release may contain forward-looking statements, about Can-Fite’s expectations, beliefs or intentions regarding, among other things, its product development efforts, business, financial condition, results of operations, strategies or prospects. All statements in this communication, other than those relating to historical facts, are “forward looking statements”. Forward-looking statements can be identified by the use of forward-looking words such as “believe,” “expect,” “intend,” “plan,” “may,” “should” or “anticipate” or their negatives or other variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical or current matters. Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to known and unknown risks, uncertainties and other factors that may cause Can-Fite’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause actual results, performance or achievements to differ materially from those anticipated in these forward-looking statements include, among other things, our history of losses and needs for additional capital to fund our operations and our inability to obtain additional capital on acceptable terms, or at all; uncertainties of cash flows and inability to meet working capital needs; the initiation, timing, progress and results of our preclinical studies, clinical trials and other product candidate development efforts; our ability to advance our product candidates into clinical trials or to successfully complete our preclinical studies or clinical trials; our receipt of regulatory approvals for our product candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of our product candidates; our ability to establish and maintain strategic partnerships and other corporate collaborations; the implementation of our business model and strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and our ability to operate our business without infringing the intellectual property rights of others; competitive companies, technologies and our industry; risks related to any resurgence of the COVID-19 pandemic and the war between Israel and Hamas; risks related to not satisfying the continued listing requirements of NYSE American; and statements as to the impact of the political and security situation in Israel on our business. More information on these risks, uncertainties and other factors is included from time to time in the “Risk Factors” section of Can-Fite’s Annual Report on Form 20-F filed with the SEC on March 28, 2024 and other public reports filed with the SEC and in its periodic filings with the TASE. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Can-Fite undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. View source version on businesswire.com: Contacts Can-Fite BioPharma Motti Farbstein info@canfite.com +972-3-9241114 Source: Can-Fite BioPharma Ltd. View this news release online at:

Orphan DrugClinical ResultPhase 3Phase 2Fast Track

15 Jan 2024

·www.drugs.com

Viagra, Cialis Plus a Heart Med Could Be a Dangerous Combo

MONDAY, Jan. 15, 2024 -- Taking nitrates for heart problems alongside erectile dysfunction drugs like Viagra or Cialis could be a prescription for trouble, a new study warns. Men who combine the two types of medications have a higher risk of death or suffering a heart-related health emergency, researchers reported Jan. 15 in the Journal of the American College of Cardiology . “Physicians are seeing an increase of requests for erectile dysfunction drugs from men with cardiovascular diseases,” said senior researcher Dr. Daniel Peter Andersson , an associate professor at the Karolinska Institute in Sweden. “Patients taking nitrates may experience an increased risk of negative health outcomes.” Viagra, Cialis, Levitra and others are posphodiesterase type 5 inhibitors (PDE5i). They work by widening arteries and increasing blood flow to the penis. Nitrates also work by dilating blood vessels, and are used to treat chest pain associated with angina and to ease symptoms of heart failure. Both types of drugs can cause drops in blood pressure, so guidelines recommend they not be used together. But researchers said the number of people prescribed both is growing, and there’s little real-world data on the implications of using them at the same time. For this study, researchers analyzed health records for nearly 61,500 men prescribed nitrates who’d had a heart attack or had undergone a procedure to open blocked coronary arteries. Among those men, more than 5,700 also had been prescribed an erectile dysfunction drug. The data revealed that men taking both drugs had an overall higher risk of death, as well as of heart attack, heart failure and other major cardiovascular events. Few events occurred within 28 days of men receiving an erectile dysfunction drug, indicating that there is low immediate risk, researchers said. “Our goal is to underscore the need for careful patient-centered consideration before prescribing PDE5i medication to men receiving nitrate treatment,” Andersson said in an American College of Cardiology news release. “Furthermore, it justifies our efforts for continued research into the ambiguous effects of ED drugs on men with CVD [cardiovascular disease].” In an accompanying editorial, Dr. Glenn Levine said erectile dysfunction drugs are reasonably safe in men with mild angina in good physical shape, but using them with an ongoing nitrate prescription is ill-advised at best. “ED and CAD [coronary artery disease] are unfortunate, and all too common, bedfellows,” said Levine, a professor of cardiology with Baylor College of Medicine in Houston. “But, as with most relationships, assuming proper precautions and care, they can co-exist together for many years -- perhaps even a lifetime.” Sources American College of Cardiology, news release, Jan. 15, 2024 Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions. Posted January 2024 More news resources FDA Medwatch Drug Alerts Daily MedNews News for Health Professionals New Drug Approvals New Drug Applications Drug Shortages Clinical Trial Results Generic Drug Approvals Subscribe to our newsletter Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

100 Deals associated with Vardenafil Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
-	Vardenafil Hydrochloride	G04BE09	DB00862

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Erectile Dysfunction	EU	Bayer AG	04 Mar 2003
Erectile Dysfunction	IS	Bayer AG	04 Mar 2003
Erectile Dysfunction	LI	Bayer AG	04 Mar 2003
Erectile Dysfunction	NO	Bayer AG	04 Mar 2003

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Sexual Dysfunction	Phase 3	JP	Bayer AG	01 Mar 2004
Spinal Injuries	Phase 3	JP	Bayer AG	01 Mar 2004
Diabetes Mellitus	Phase 3	-	Bayer AG	01 Jan 2004
Depression	Phase 3	US	Bayer AG	01 Dec 2002
Depression	Phase 3	CA	Bayer AG	01 Dec 2002
Depression	Phase 3	FR	Bayer AG	01 Dec 2002
Depression	Phase 3	IT	Bayer AG	01 Dec 2002
Depression	Phase 3	ES	Bayer AG	01 Dec 2002
Depressive Disorder	Phase 3	US	Bayer AG	01 Dec 2002
Depressive Disorder	Phase 3	CA	Bayer AG	01 Dec 2002

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ERS2020	Not Applicable	-	-	vardenafil	cabmkcrbzj(bzawiivbiq) = iyymeombiy jufmftaybm (ypsliifkzp ) View more	Positive	07 Sep 2020
ESC2018	Not Applicable	-	-	Vardenafil	rslecneaqp(owruujspiu) = wtsjshrysl obvfvllbqe (suzxyggiyb )	-	22 Apr 2018
				ZDF with vehicle (ZDFLV)	rslecneaqp(owruujspiu) = tebyomwmim obvfvllbqe (suzxyggiyb )
NCT01106118 (Pubmed \| Sex Med) Manual	Not Applicable	Metabolic Syndrome \| Erectile Dysfunction	1,832	vardenafil	binxsiuhwe(qaxqvlxqpm) = ujdwgmgfhw upxguibroz (sinwaykvhr ) View more	Positive	01 Sep 2016
NCT00631969 \| NCT00655629 (Pubmed \| J Sex Med)	Phase 3	Erectile Dysfunction	-	Vardenafil ODT	whejfdhnyx(usgvvmlnod) = lauglzjbwc cwjerhtraa (zctiinuafu )	-	01 Oct 2011
				Placebo	whejfdhnyx(usgvvmlnod) = xykqgqqnxw cwjerhtraa (zctiinuafu )
NCT00738400 (ED-METABOLIC, CTgov)	Phase 4	Metabolic Syndrome \| Erectile Dysfunction	150	Vardenafil (Levitra, BAY38-9456) (Vardenafil (Levitra, BAY38-9456))	fffmdkglwf(issqpxlyzz) = eaaekllfzz xhpzzacrix (yuiyrwiwgg, abtljvqdya - rxjzgafibm) View more	-	01 Jun 2011
				Placebo (Placebo)	fffmdkglwf(issqpxlyzz) = eubrcrcupz xhpzzacrix (yuiyrwiwgg, elngjejihm - kkuyuofbkm) View more
NCT00631969 (CTgov)	Phase 3	Erectile Dysfunction	362	Vardenafil ODT (STAXYN, BAY38-9456) (Vardenafil ODT (STAXYN, BAY38-9456))	wffpwlyhea(ljbmyflznc) = aeyaotndwi rftgjpgdpf (mniusinpwe, lazbhantae - ntkpsrqoci) View more	-	21 Jan 2011
				Placebo (Placebo)	wffpwlyhea(ljbmyflznc) = wxgfblwqmx rftgjpgdpf (mniusinpwe, kviqflghsk - fvfqtvdfnj) View more
NCT00655629 (CTgov)	Phase 3	Erectile Dysfunction	339	Vardenafil ODT (STAXYN, BAY38-9456) (Vardenafil ODT (STAXYN, BAY38-9456))	bdqcfifqjo(ctvmmtodyf) = lcbjwgzuik cepznvmhew (xkyqvucont, nmqkigluux - hxahiuejau) View more	-	21 Jan 2011
				Placebo (Placebo)	bdqcfifqjo(ctvmmtodyf) = lhyyhvgdsa cepznvmhew (xkyqvucont, wzdfcunqjg - vospewvaru) View more
AUA2010	Not Applicable	Prostatic Diseases	-	Vardenafil 20 mg	nnvnntzmcx(fcnkjcqqga) = scgneeecgy yvqakotmmx (larnjjuzqa )	Positive	01 Apr 2010
NCT00478881 (CTgov)	Phase 2	Urinary Bladder, Overactive	397	Vardenafil HCl (Levitra, BAY38-9456) (Vardenafil HCl (Levitra, BAY38-9456))	ftrkfbvtgq(zxplejfjeq) = zaepfaqjya hoctmffptz (mzgmwickjf, dvqxtnqpwd - bboqmujisf) View more	-	24 Dec 2009
				Placebo (Placebo)	ftrkfbvtgq(zxplejfjeq) = hcbxqvvdkj hoctmffptz (mzgmwickjf, oymbzyitvy - qckzsyozee) View more
NCT00853840 (CTgov)	Phase 4	Acquired Immunodeficiency Syndrome	18	Vardenafil+Maraviroc (Maraviroc + Vardenafil (Treatment A))	wgpvapulju(lsmlwcpwhp) = hxkrkzfcyb kgyzfuknru (kfflwfpkvo, dwboytckhy - irozjoafbd) View more	-	23 Jun 2009
				Placebo+Maraviroc (Maraviroc + Placebo (Treatment B))	wgpvapulju(lsmlwcpwhp) = geoswdfbde kgyzfuknru (kfflwfpkvo, bswrcywxuw - zqbkmikekg) View more

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