A Double-blind, Randomized, Parallel Design Two Center Study to Compare the Effect of Vorapaxar vs. Placebo on Lower Extremity Vein Graft Maturation, Remodeling, and Function

There are no medical therapies indicated for reduction of limb ischemic events. Studies of dual-antiplatelet therapy with aspirin and clopidogrel versus aspirin alone (CASPAR) as well as studies of systemic anticoagulation (WAVE) have shown no benefit for either strategy in the reduction in limb vascular events. Surgical bypass grafting involves harvesting of the vein, warm ischemia with disruption of vaso vasorum, ischemia-reperfusion, and finally heightened hemodynamic stress in the new arterial environment. Vein grafts rapidly remodel in response to the increase in blood flow and pressure in an attempt to normalize them into physiological range. The investigators have previously identified 3 distinct temporal phases of the remodeling process: During the first 30 days following implantation is a critical period of luminal enlargement which appears to be an endothelium-independent process. The second phase occurs between 1 and 3 months and represents a period of stiffening of the vein graft indicating synthesis of fibrous proteins. The third period is referred to as biochemical remodeling wherein the vein recovers clinically measureable endothelial function. It is likely diabetes mellitus impacts each of these phases. TRA2°P-TIMI 50 demonstrated a reduction in acute limb ischemic (ALI) events (42% reduction) and urgent peripheral arterial revascularizations (35% reduction), a finding unique among medical therapies. While the temporal trend in reduction in ALI events occurred early and late after exposure suggestion an antithrombotic mechanism, the reduction in elective revascularization occurred later suggested beneficial effects beyond platelet inhibition. The purpose of this trial is to study the physiological impact of vorapaxar on lower extremity bypass graft maturation and function.

Start Date01 Oct 2017

Sponsor / Collaborator

Vanderbilt University

[+1]

NCT02660866

/ Unknown statusPhase 4

Excellence In Peripheral Artery Disease Thrombin Receptor Antagonist Intervention In Claudication Evaluation (XLPAD-TRACE Trial)

This is a Phase 4, randomized clinical trial to evaluate whether addition of Vorapaxar 2.08 mg daily vs. placebo daily on background antiplatelet therapy, prescribed for 6 months to patients with established peripheral artery disease (PAD) and Intermittent Claudication (IC) treated with standard medical therapy (SMT) would lead to an improvement in the peak walking time (PWT).

Start Date01 Jul 2016

Sponsor / Collaborator

Northwest Texas Healthcare System, Inc.

EUCTR2016-000309-34-AT

/ Not yet recruitingPhase 2IIT

Vorapaxar in the human endotoxemia model - LPS_Vorapaxar

Start Date10 Jun 2016

Sponsor / Collaborator

Medical University of Vienna

100 Clinical Results associated with Vorapaxar Sulfate

100 Translational Medicine associated with Vorapaxar Sulfate

100 Patents (Medical) associated with Vorapaxar Sulfate

1,075

Literatures (Medical) associated with Vorapaxar Sulfate

01 Jan 2026·AMERICAN HEART JOURNAL

Distal versus conventional transradial artery access for coronary catheterization in patients with STEMI (DR-STEMI): Rationale and design of an international, multicenter, randomized trial

Article

Author: Karanasos, Antonios ; Apostolos, Anastasios ; Ruzsa, Zoltán ; Mugnolo, Antonio ; Stougiannos, Pavlos ; Gasparini, Gabriele L ; Davlouros, Periklis ; Didagelos, Matthaios ; Papafaklis, Michael ; Trigka-Vasilakopoulou, Aikaterini ; Moulias, Athanasios ; Ziakas, Antonios ; Sgueglia, Gregory A ; Xaplanteris, Panagiotis ; Timpilis, Filippos ; Tsiafoutis, Ioannis ; Iglesias, Juan F ; Sciahbasi, Alessandro ; Hamilos, Michalis ; Aminian, Adel ; Colletti, Giuseppe ; Pappas, Loukas ; Tsigkas, Grigorios ; Ungureanu, Claudiu ; Nikas, Dimitrios ; Michalis, Lampros ; Poulimenos, Leonidas E

RATIONALE:

Transradial access (TRA) constitutes the cornerstone for cardiac catheterization and is recommended by the multiple recent guidelines, irrespective of clinical presentation. The existing literature has evaluated distal transradial access (dTRA), as a feasible and safe approach in patients with chronic and acute coronary syndrome, excluding although patients presenting with ST- elevation myocardial infraction (STEMI).

PRIMARY HYPOTHESIS:

The current randomized clinical trial compares dTRA versus conventional TRA access in patients with STEMI undergoing coronary angiography and interventions regarding peri‑ and postprocedural characteristics.

DESIGN:

DR-STEMI is a prospective, open label, European, multicenter randomized-control trial which will include 554 patients (277 patients in each treatment arm). Patients with STEMI, will be screened on an all-comers basis for study inclusion and exclusion criteria, and those eligible will be allocated randomly (1:1), to dTRA versus TRA approach. The primary hypothesis of the study is that dTRA is noninferior to conventional TRA regarding the required time between the puncture of the radial artery and wire crossing of the infarct-related artery (i.e., needle-to-wire time).

CURRENT STATUS:

Enrollment for the DR-STEMI trial began in May 2024, and as of April 15th^, 2025, 309 patients have been enrolled in the study. Recruitment is expected to continue for approximately 12 months.

TRIAL REGISTRATION:

clinicaltrials.gov: NCT05605288.

01 Dec 2025·Comparative Biochemistry and Physiology D-Genomics & Proteomics

Beyond opioid and SNRI-like actions: Proteomic insights into the effects of tramadol and O-desmethyltramadol in zebrafish larvae

Article

Author: Rodrigues, Pedro ; Carvalho, António Paulo ; Campos, Alexandre ; Turkina, Maria V ; Araújo, Mário Jorge ; Guimarães, Laura ; Oliva-Teles, Luís

The presence of pharmaceuticals in natural habitats is an increasing concern. In particular, the antidepressant tramadol (TRA) and its metabolite o-desmethyltramadol (OTRA) have become ubiquitous compounds in aquatic ecosystems. However, investigation of their impact on fish, particularly on their proteome, still needs attention. Therefore, this work assesses the alterations in the proteome of zebrafish larvae caused by TRA or OTRA exposure. Zebrafish larvae (0-3 h post-fertilization, hpf) were exposed to 0.1 or 100 μg/L of TRA or OTRA until reaching 168 hpf. The larvae proteome was then investigated through shotgun proteomics, employing the filter-aided sample preparation method (FASP) followed by high-throughput LC-MS/MS analysis. Coupling mass spectrometry quantification with a saturated orthogonal multiple linear regression analysis provided identification of differentially expressed proteins (DEPs). Finally, the functional analysis of these DEPs was performed with STRING-DB online tool to identify possible molecular pathways affected by the treatments. A total of 162 DEPs were identified, with the highest number observed in larvae exposed to the lower TRA concentration. These highlights possible non-monotonic responses and supports previously described effects for other endpoints, which may affect the serotonergic, noradrenergic and opioid systems. The Kyoto Encyclopedia of Genes and Genomes (KEGG) pathway analysis also indicated putative alterations in metabolic pathways e.g., Glycolysis/Gluconeogenesis, Tricarboxylic Acid Cycle (TCA), Oxidative phosphorylation, Pyruvate metabolism, and Carbon metabolism. Our results suggest that TRA and OTRA exposure may impact vital biological processes in fish larvae, emphasizing the need for adequate integrated monitoring of tramadol, its metabolites, and effects in aquatic ecosystems.

01 Nov 2025·NEUROSURGERY

Transradial Versus Transfemoral Access for Mechanical Thrombectomy in Acute Ischemic Stroke: An Update Meta-Analysis and Trial Sequential Analysis

Review

Author: Figueiredo, Eberval G. ; Batista, Savio ; Bertani, Raphael ; Brenner, Leonardo B. O. ; Carvalho Leite Romeiro, Pedro Henrique ; Koppanatham, Aishwarya ; Cavalcanti, Daniel D. ; Punukollu, Anuraag

BACKGROUND AND OBJECTIVE::

Transfemoral access (TFA) is the standard for mechanical thrombectomy (MT) in acute ischemic stroke (AIS). Transradial access (TRA) is a feasible alternative. Despite advances, no recent systematic review or meta-analysis exists, highlighting the need for updated evidence.

METHODS::

Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, databases were searched up to February 2024 for articles comparing TRA with TFA for MT in AIS. Studies were included if they reported at least one outcome, with at least 10 patients per group. Random-effects models were applied, with odds ratios (ORs) used for dichotomous outcomes and mean differences (MDs) for continuous outcomes.

RESULTS::

Our analysis included 763 TRA patients and 3527 TFA patients, with one randomized study and nine observational studies. We found no significant differences in successful recanalization (OR 0.88, 95% CI: 0.59-1.32), complete recanalization (OR 1.15, 95% CI: 0.92-1.43), first pass effect (OR 0.83, 95% CI: 0.68-1.01), puncture-to-recanalization time (MD −1.67, 95% CI: −7.48 to 4.13), access site complications (OR 0.70, 95% CI: 0.28-1.76), symptomatic intracranial hemorrhage (OR 0.93, 95% CI: 0.62-1.39), crossover (OR 1.71, 95% CI: 0.75-3.92), number of passes (MD 0.17, 95% CI: −0.08-0.41), length of hospitalization (MD −0.59, 95% CI: −1.28-0.09), and favorable outcomes at 3 months (OR 0.85, 95% CI: 0.58-1.23). Trial sequential analysis showed that successful recanalization, puncture-to-recanalization time, and first pass effect did not reach the required information size, indicating inconclusive results, whereas access complications analysis suggested a high probability of similarity between the two treatments.

CONCLUSION::

TRA is a viable alternative to TFA for MT in AIS, with comparable safety and efficacy. Although current evidence does not support widespread adoption, the introduction of radial-specific devices and advancements in operator training could improve outcomes. Further randomized trials with larger sample sizes are needed to clarify TRA's role and optimize neurointerventional practices compared with TFA.

News (Medical) associated with Vorapaxar Sulfate

17 Jun 2024

·www.globenewswire.com

Blue Water Biotech Teams with BFW Advertising to Market and Advertise Commercial Product Portfolio

CINCINNATI, July 06, 2023 (GLOBE NEWSWIRE) -- Blue Water Biotech, Inc. (“Blue Water” or the “Company”) (Nasdaq: BWV), a biotechnology and pharmaceutical company focused on developing and commercializing transformational therapies to address significant health challenges globally, today announced the signing of a Master Services Agreement with bfw Advertising Inc. (“bfw”) to generate marketing and advertising material for Blue Water’s commercial stage drug portfolio. Based in Boca Raton, Florida, bfw has more than three decades of experience supporting clinical and commercial stage life science companies, generating effective and impactful brand campaigns, including digital, direct to consumer, and health care provider content. Bfw will work with Blue Water’s commercial team to increase awareness for its commercial products through patient-facing materials, website updates, social ads, targeted provider engagement, as well as materials to support Blue Water’s sales team, among other services. “Signing this agreement and generating an action plan with bfw is a critical step in the execution of our commercial launch strategy for our products,” said Joseph Hernandez, Chairman and Chief Executive Officer of Blue Water. “By creating targeted, effective marketing materials, we can maximize patient, healthcare provider, and payor awareness to ensure long-term success for Blue Water. With their impressive history of campaigns in the life science industry, we are confident that bfw is the right firm for this endeavor, and we look forward to the official launches of these programs in the coming months.” “With their recent acquisitions and shift into a commercial-stage as well as clinical-stage company, this is certainly an exciting time for the team at Blue Water,” said Christian Boswell, President and Creative Director at bfw. “Through decades of working in the life science industry, we understand the intricacies of marketing and advertising in this space and how challenging it can be for pharmaceutical companies to create cohesive brands. Blue Water has built a strong portfolio of products in recent months, and we are honored to utilize our institutional knowledge to support them and to help them navigate the commercial arena.” Blue Water recently expanded its operations to become a commercial stage company with the acquisition of several FDA approved assets across multiple indications, including urology, cardiology, inner ear infections and pain management. Blue Water’s commercial team will work closely with BFW to identify key areas where targeted advertising and marketing support can enhance product uptake and utilization in each respective market. About Blue Water Biotech Blue Water Biotech, Inc. is a biotechnology and pharmaceutical company focused on developing and commercializing transformational therapies to address significant health challenges globally. Headquartered in Cincinnati, OH, the Company owns ENTADFI®, an FDA-approved, once daily pill that combines finasteride and tadalafil for the treatment of benign prostatic hyperplasia. This combination allows men to receive treatment for their symptoms of benign prostatic hyperplasia without the negative sexual side effects typically seen in patients on finasteride alone. The Company also has a robust vaccine pipeline. Blue Water holds the rights to proprietary technology developed at the University of Oxford, Cincinnati Children’s Hospital Medical Center, St. Jude Children’s Hospital, and The University of Texas Health Science Center at San Antonio. Blue Water is developing a Streptococcus pneumoniae vaccine candidate, designed to specifically prevent highly infectious middle ear infections, known as AOM, in children, and prevention of pneumonia in the elderly. The Company is also developing a universal flu vaccine that will provide protection from all virulent strains in addition to licensing a novel norovirus S&P nanoparticle versatile virus-like particle vaccine platform from Cincinnati Children’s to develop vaccines for multiple infectious diseases, including Marburg and monkeypox, among others. Additionally, the Company is developing a Chlamydia vaccine candidate with UT Health Science Center San Antonio to prevent infection and reduce the need for antibiotic treatment associated with contracting Chlamydia disease. For more information about Blue Water, visit www.bwbioinc.com. About BFW Advertising Bfw is a full-service integrated branding and communications agency with a strong grounding in healthcare and pharma, supporting both clinical and commercial stage companies. Bfw has worked across a broad range of brands and therapeutic areas, including men’s and women’s health, CNS, pediatrics, oncology, pain management, pulmonary and HIV-associated disorders, as well as leading recruiting campaigns for clinical trial participants. Cautionary Note Regarding 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 anticipated benefits of the Company’s agreement with BFW and the Company’s sales and marketing efforts as described herein) are based on Blue Water’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, risks related to Blue Water’s ability to realize the benefits of its acquisitions of ENTADFI®, ZONTIVITY®, OTOVEL®, CETRAXAL®, CONJUPRI®, TREZIX™ and NALFON®; risks related to Blue Water’s ability to expand its business scope, commercialize ENTADFI® and integrate the assets and commercial operations being acquired from WraSer into Blue Water’s business; risks related to Blue Water’s ability to attract, hire and retain skilled personnel and establish an effective sales team; risks related to Blue Water’s ability to enter into a definitive agreement with IQVIA and optimize its collaboration with IQVIA; risks related to the development of Blue Water’s vaccine candidates; the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations;; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. 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 pharmaceutical products. Blue Water does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in Blue Water’s Annual Report on Form 10-K, filed with the Securities and Exchange Commission (the “SEC”) on March 9, 2023 and periodic reports filed with the SEC on or after the date thereof. All of Blue Water’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. Media Contact Information:Blue Water Media RelationsTelephone: (646) 942-5591 Email: Nic.Johnson@russopartnersllc.com Investor Contact Information:Blue Water Investor RelationsEmail: investors@bwbioinc.com

Vaccine

17 Jun 2024

·www.globenewswire.com

Blue Water Biotech and Knipper Health Join Forces to Distribute Samples for ENTADFI® and ZONTIVITY® to Physicians

CINCINNATI, July 31, 2023 (GLOBE NEWSWIRE) -- Blue Water Biotech, Inc. (“Blue Water” or the “Company”) (Nasdaq: BWV), a biotechnology and pharmaceutical company focused on developing and commercializing transformational therapies to address significant health challenges globally, today announced an agreement with Knipper Health, Inc. (“Knipper Health”) to manage the inventory and distribution of product samples to sales representatives for ENTADFI® and ZONTIVITY®. Knipper Health has more than 35 years of experience building and maintaining operations for healthcare clients, including sample management, custom pharmacy solutions and 3PL services. As part of Blue Water’s product roll-out plans, Knipper Health will oversee sample inventory and ship samples on request to the sales force in the field. This will help to expedite physicians’ initiation of therapy for their patients while increasing familiarity with the products. “This agreement is another step toward placing our commercial products into the hands of physicians and the patients in need,” said Joseph Hernandez, Chairman and Chief Executive Officer of Blue Water. “We are moving forward with our aggressive timelines and will continue to provide updates on our launch progress. Most importantly is our collaboration with proven industry partners such as Knipper Health, that will help to make the product launches successful. These agreements and partnerships will be critical to ensure not only the successful launch of these products, but to maximize long term access to potentially life-saving medications for patients.” Blue Water purchased ENTADFI® in April 2023, followed by an asset purchase agreement for six FDA-approved assets, including ZONTIVITY®, that is expected to close later this year. Since the execution of those agreements, the Company has made significant commercialization progress with market access and distribution. Blue Water has executed agreements that cover market access and payor coverage, marketing and advertising, telehealth services generation and sales force development. About ENTADFI® ENTADFI® is a once daily, oral treatment for BPH that combines finasteride, a 5α-reductase inhibitor, and tadalafil, a phosphodiesterase 5 (PDE5) inhibitor, offering a more effective treatment option compared to other available therapies. Clinical trials have shown that ENTADFI® is more effective in treating BPH symptoms, including urinary frequency, urgency, weak stream, and difficulty initiating or maintaining urination, compared to finasteride monotherapy. Additionally, ENTADFI® has demonstrated a favorable safety profile, with fewer adverse sexual side effects compared to finasteride. ENTADFI® reduces potential for adverse sexual side effects, making it a preferred choice for men seeking relief from BPH symptoms without compromising their sexual health. ENTADFI® has received FDA approval for the indication of initiating treatment of the signs and symptoms of BPH in men with an enlarged prostate for up to 26 weeks. More information about BPH and full ENTADFI® prescribing information can be found on the product website at https://entadfipatient.com/. About ZONTIVITY® ZONTIVITY® is a once daily, oral treatment indicated for the reduction of thrombotic cardiovascular events for patients with a history of myocardial infarction (MI) or with peripheral arterial disease (PAD). ZONTIVITY® has been shown to reduce the rate of a combined endpoint of cardiovascular death, MI, stroke, and urgent coronary revascularization when used with aspirin and/or clopidogrel. More information about MI, PAD, and full ZONTIVITY® prescribing information can be found on the product website at https://zontivity.com/. About Knipper Health Knipper Health is a leading healthcare solutions company serving the pharmaceutical, biotechnology, and medical device industries for more than 35 years, with a focus on sample management and marketing, custom pharmacy solutions and 3PL services. Knipper has become the single source-provider of samples management services for many small, to large pharmaceutical customers. KnippeRx is a highly nimble, independent specialty pharmacy that serves both commercial and non-commercial needs. KnippeRx helps overcome the complex barriers to patient access by providing the shortest path from initiation of a prescription to delivery of essential therapy. Knipper 3PL provides storage and distribution of CRT, Cold Chain, Frozen, and DEA III-V products along with full order to cash, chargebacks, and contract management services. About Blue Water Biotech Blue Water Biotech, Inc. is a biotechnology and pharmaceutical company focused on developing and commercializing transformational therapies to address significant health challenges globally. Headquartered in Cincinnati, OH, the Company owns ENTADFI®, an FDA-approved, once daily pill that combines finasteride and tadalafil for the treatment of benign prostatic hyperplasia. This combination allows men to receive treatment for their symptoms of benign prostatic hyperplasia without the negative sexual side effects typically seen in patients on finasteride alone. The Company is also in the process of acquiring approved therapies from WraSer, LLC, and Xspire Pharma, LLC, including ZONTIVITY® (reduction of thrombotic cardiovascular events in patients with myocardial infarction or with peripheral arterial disease), OTOVEL® (acute otitis media with tympanostomy tubes), CETRAXAL® (acute otitis externa), CONJUPRI® (hypertension), TREZIX™ (moderate to severe pain) and NALFON® (NSAID treatment for pain and inflammation). The Company also has a robust preclinical vaccine pipeline. Blue Water holds the rights to proprietary technology developed at the University of Oxford, Cincinnati Children’s Hospital Medical Center, St. Jude Children’s Hospital, and The University of Texas Health Science Center at San Antonio. Blue Water is developing a Streptococcus pneumoniae vaccine candidate, designed to specifically prevent highly infectious middle ear infections, known as AOM, in children, and prevention of pneumonia in the elderly. The Company is also developing a universal flu vaccine that will provide protection from all virulent strains in addition to licensing a novel norovirus S&P nanoparticle versatile virus-like particle vaccine platform from Cincinnati Children’s to develop vaccines for multiple infectious diseases, including Marburg and monkeypox, among others. Additionally, the Company is developing a Chlamydia vaccine candidate with UT Health Science Center San Antonio to prevent infection and reduce the need for antibiotic treatment associated with contracting Chlamydia disease. For more information about Blue Water, visit www.bwbioinc.com. Cautionary Note Regarding 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 anticipated benefits of the Company’s agreements with Knipper, UpScript, IQVIA, APS and bfw and the anticipated results of the Company’s sales and marketing efforts for its commercial stage products as described herein) are based on Blue Water’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, risks related to Blue Water’s ability to realize the benefits of its acquisitions of ENTADFI®, ZONTIVITY®, OTOVEL®, CETRAXAL®, CONJUPRI®, TREZIX™ and NALFON®; risks related to Blue Water’s ability to expand its business scope, commercialize ENTADFI® and integrate the assets and commercial operations being acquired from WraSer, LLC, and Xspire Pharma, LLC into Blue Water’s business; risks related to Blue Water’s ability to attract, hire and retain skilled personnel and establish an effective sales team; risks related to Blue Water’s ability to establish, maintain and optimize key third party commercial collaboration agreements (such as those with Knipper, UpScript, IQVIA, APS and bfw); risks related to the Company’s present need for capital to close its asset acquisitions, commercially launch the Company’s acquired products and have adequate working capital; risks related to the development of Blue Water’s vaccine candidates; the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the timing and progress of clinical development of our product candidates; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. 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 pharmaceutical products. Blue Water does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in Blue Water’s Annual Report on Form 10-K, filed with the Securities and Exchange Commission (the “SEC”) on March 9, 2023 and periodic reports filed with the SEC on or after the date thereof. All of Blue Water’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. Media Contact Information:Blue Water Media RelationsTelephone: (646) 942-5591Email: Nic.Johnson@russopartnersllc.com Investor Contact Information:Blue Water Investor RelationsEmail: investors@bwbioinc.com

AcquisitionVaccine

17 Jun 2024

·www.globenewswire.com

Blue Water Biotech Announces Exercise of Warrants and Issuance of New Warrants in A Private Placement For $2.7 Million Gross Proceeds

CINCINNATI, Aug. 01, 2023 (GLOBE NEWSWIRE) -- Blue Water Biotech, Inc. ("Blue Water" or the “Company”) (Nasdaq: BWV), today announced it has entered into a definitive agreement for the exercise of certain existing warrants to purchase 2,486,214 shares of its common stock at a reduced exercise price of $1.09 per share, in exchange for new warrants as described below. The aggregate gross proceeds from the exercise of the existing warrants is expected to total approximately $2.7 million, before deducting placement agent fees and other offering expenses payable by the Company. The transaction is expected to close on or about August 2, 2023, subject to satisfaction of customary closing conditions. H.C. Wainwright is acting as the exclusive placement agent for this transaction. The Company expects to use the net proceeds from the transaction for working capital and general corporate purposes, including executing on launch activities for Blue Water’s commercial portfolio announced in a letter to shareholders issued earlier this month. The shares of common stock issuable upon exercise of the existing warrants are registered pursuant to an existing registration statement on a Post-Effective Amendment No. 1 to Form S-1 on Form S-3 (File No. 333-267142), declared effective by the Securities and Exchange Commission (the “SEC”) on May 4, 2023. In consideration for the immediate exercise of the existing warrants for cash, the Company will issue new unregistered warrants to purchase shares of common stock in a private placement pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended (the "1933 Act"). The shares of common stock issuable upon exercise of the new warrants is subject to stockholder approval. The Company agreed to convene a stockholders’ meeting on or before 90 days following the closing date of the transaction to obtain such approval. The new warrants will be exercisable for up to an aggregate of 4,972,428 shares of common stock, at an exercise price of $1.09 per share and have a term of exercise equal to five years from the date of stockholder approval. The new warrants offered in the private placement have not been registered under the 1933 Act, or applicable under state securities laws. Accordingly, the new warrants and shares of common stock issuable upon the exercise of the new warrants may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. As part of the offering, the Company has agreed to file a resale registration statement on Form S-3 with the SEC as soon as practicable to register the resale of the shares of common stock issuable upon the exercise of the new warrants issued in the private placement, and to have such resale registration statement declared effective within 90 days following the date of the agreement. This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction. About Blue Water Biotech Blue Water Biotech, Inc. is a biotechnology and pharmaceutical company focused on developing and commercializing transformational therapies to address significant health challenges globally. Headquartered in Cincinnati, OH, the Company owns ENTADFI®, an FDA-approved, once daily pill that combines finasteride and tadalafil for the treatment of benign prostatic hyperplasia. This combination allows men to receive treatment for their symptoms of benign prostatic hyperplasia without the negative sexual side effects typically seen in patients on finasteride alone. The Company is also in the process of acquiring approved therapies from WraSer, LLC, and Xspire Pharma, LLC, including ZONTIVITY® (reduction of thrombotic cardiovascular events in patients with myocardial infarction or with peripheral arterial disease), OTOVEL® (acute otitis media with tympanostomy tubes), CETRAXAL® (acute otitis externa), CONJUPRI® (hypertension), TREZIX™ (moderate to severe pain) and NALFON® (NSAID treatment for pain and inflammation). The Company also has a robust preclinical vaccine pipeline. Blue Water holds the rights to proprietary technology developed at the University of Oxford, Cincinnati Children’s Hospital Medical Center, St. Jude Children’s Hospital, and The University of Texas Health Science Center at San Antonio. Blue Water is developing a Streptococcus pneumoniae vaccine candidate, designed to specifically prevent highly infectious middle ear infections, known as AOM, in children, and prevention of pneumonia in the elderly. The Company is also developing a universal flu vaccine that will provide protection from all virulent strains in addition to licensing a novel norovirus S&P nanoparticle versatile virus-like particle vaccine platform from Cincinnati Children’s to develop vaccines for multiple infectious diseases, including Marburg and monkeypox, among others. Additionally, the Company is developing a Chlamydia vaccine candidate with UT Health Science Center San Antonio to prevent infection and reduce the need for antibiotic treatment associated with contracting Chlamydia disease. For more information about Blue Water, visit www.bwbioinc.com. Cautionary Note Regarding 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, statements regarding the completion of the offering, the satisfaction of customary closing conditions, the intended use of proceeds from the offering, the anticipated benefits of the Company’s agreements with Knipper, UpScript, IQVIA, APS and bfw and the anticipated results of the Company’s sales and marketing efforts for its commercial stage products as described herein) are based on Blue Water’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 Blue Water’s ability to realize the benefits of its acquisitions of ENTADFI®, ZONTIVITY®, OTOVEL®, CETRAXAL®, CONJUPRI®, TREZIX™ and NALFON®; risks related to Blue Water’s ability to expand its business scope, commercialize ENTADFI® and integrate the assets and commercial operations being acquired from WraSer, LLC, and Xspire Pharma, LLC into Blue Water’s business; risks related to Blue Water’s ability to attract, hire and retain skilled personnel and establish an effective sales team; risks related to Blue Water’s ability to establish, maintain and optimize key third party commercial collaboration agreements (such as those with Knipper, UpScript, IQVIA, APS and bfw); risks related to the Company’s present need for capital to close its asset acquisitions, commercially launch the Company’s acquired products and have adequate working capital; risks related to the development of Blue Water’s vaccine candidates; the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the timing and progress of clinical development of our product candidates; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. 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 pharmaceutical products. Blue Water does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in Blue Water’s Annual Report on Form 10-K, filed with the SEC on March 9, 2023 and periodic reports filed with the SEC on or after the date thereof. All of Blue Water’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. Media Contact Information:Blue Water Media RelationsTelephone: (646) 942-5591Email: Nic.Johnson@russopartnersllc.com Investor Contact Information:Blue Water Investor RelationsEmail: investors@bwbioinc.com

Vaccine

100 Deals associated with Vorapaxar Sulfate

External Link

KEGG	Wiki	ATC	Drug Bank
D09766	Vorapaxar Sulfate	B01AC26	DB09030

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Arterial thrombosis	Canada	Xspire Pharma LLC	28 Oct 2022
Coronary Disease	United States	Key Therapeutics, LLC	08 May 2014
Myocardial Infarction	United States	Key Therapeutics, LLC	08 May 2014
Peripheral Arterial Disease	United States	Key Therapeutics, LLC	08 May 2014
Stroke	United States	Key Therapeutics, LLC	08 May 2014
Thrombosis	United States	Key Therapeutics, LLC	08 May 2014

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute Coronary Syndrome	Phase 3	-	Merck Sharp & Dohme Corp.	01 Dec 2007
Atherosclerosis	Phase 3	-	Merck Sharp & Dohme Corp.	01 Dec 2007
Non-St Elevated Myocardial Infarction	Phase 3	-	Merck Sharp & Dohme Corp.	01 Dec 2007
Ischemia	Phase 3	-	Merck Sharp & Dohme LLC	01 Sep 2007
Ischemic stroke	Phase 3	-	Merck Sharp & Dohme LLC	01 Sep 2007
Blood Coagulation Disorders	Phase 2	United States	Merck Sharp & Dohme Corp.	01 Sep 2015
Blood Coagulation Disorders	Phase 2	Australia	Merck Sharp & Dohme Corp.	01 Sep 2015
HIV Enteropathy	Phase 2	United States	Merck Sharp & Dohme Corp.	01 Sep 2015
HIV Enteropathy	Phase 2	Australia	Merck Sharp & Dohme Corp.	01 Sep 2015
Inflammation	Phase 2	United States	-	30 Aug 2015

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03207451 (CTgov)	Phase 4	Peripheral Vascular Diseases \| Coronary Artery Disease \| Myocardial Infarction ... View more	81	Vorapaxar (Vorapaxar)	febpwtkzxm(idxjftvdai) = npjscrrhhs yjprlhtbiy (zzugmuuvid, 3) View more	-	18 Aug 2022
				Vorapaxar and Clopidogrel (Vorapaxar and Clopidogrel)	febpwtkzxm(idxjftvdai) = aevfrvhzle yjprlhtbiy (zzugmuuvid, 2) View more
NCT02545933 (VORA-PRATIC, CTgov)	Phase 4	Old myocardial infarction	130	Vorapaxar+Ticagrelor+Prasugrel+Aspirin (DAPT Plus Vorapaxar)	yqiewwaefb(tdpiunacig) = tvsdeparxm styzgjdqds (urnvccfxyp, 21) View more	-	25 Aug 2020
				Vorapaxar+Ticagrelor+Prasugrel (Prasugrel/Ticagrelor Plus Vorapaxar)	yqiewwaefb(tdpiunacig) = rorwcfqcsi styzgjdqds (urnvccfxyp, 20) View more
NCT02475837 (Pubmed \| J Vasc Access) Manual	Phase 2	Arteriovenous Fistula	13	vorapaxar	zyhtepwmys(lxhmphezel) = zysqlljcil orxtscecif (lxvxxyxiwz ) View more	Negative	01 Jul 2020
				Placebo	zyhtepwmys(lxhmphezel) = homhkzigco orxtscecif (lxvxxyxiwz ) View more
NCT00526474 (TRA 2°P-TIMI 50, Pubmed \| Vasc Med)	Phase 3	Coronary Artery Disease \| Peripheral Arterial Disease	6,136	Vorapaxar	zsmgwqhupc(eiybjgjrpp): HR = 0.85 (95% CI, 0.73 - 0.99), P-Value = 0.034 View more	-	01 Apr 2020
				Placebo
NCT02548650 (OPTIMUS-5, CTgov)	Phase 4	Myocardial Infarction \| Diabetes Mellitus \| Peripheral Arterial Disease	66	clopidogrel+Vorapaxar+Aspirin (Patients With Diabetes)	gvykgvjqzn(wibfprgorg) = lldqxyqtav vflccwgsyk (ujjgkumkxi, ubpfupxhpg - xpvhdiqtnl) View more	-	27 Jan 2020
				Clopidogrel+Vorapaxar+Aspirin (Patients Without Diabetes)	gvykgvjqzn(wibfprgorg) = sltunzfixw vflccwgsyk (ujjgkumkxi, houxfsjbnm - yzvtyhzgms) View more
NCT02875028 (CTgov)	Phase 4	Endotoxemia	16	LPS+Vorapaxar (Vorapaxar)	vztjfbzalu(kubugzvweu) = zwjphxhwhg urruhewrpk (ifkuqlyjrk, lnfpqieaeq - grnkcptcsg) View more	-	10 Jan 2020
				LPS (Placebo)	vztjfbzalu(kubugzvweu) = mgfhwelakm urruhewrpk (ifkuqlyjrk, mowbzmtfiq - evydyxltqd) View more
NCT02394730 (ADVICE, CTgov)	Phase 1/2	HIV Enteropathy \| Blood Coagulation Disorders	65	vorapaxar (Vorapaxar)	pwlfkbjdze(mnxbkcurvg) = malclczvhk ayqnimujyw (mqgdkquzbo, rjwzcemlcl - qjgsufeuvd) View more	-	28 Feb 2019
				Placebo (Placebo)	pwlfkbjdze(mnxbkcurvg) = iocndddrsf ayqnimujyw (mqgdkquzbo, metxcqpcop - rnqymtkilv) View more
NCT02475837 (CTgov)	Phase 2	Arteriovenous Fistula	17	Vorapaxar sulfate (Vorapaxar Intervention)	laatjkgkpm(wccdwmpcok) = agyytqglws wlmczyludb (scjkhpgsbm, kzrdrbeojj - kwudbxoifi) View more	-	14 Jan 2019
				Placebo (Placebo Intervention)	laatjkgkpm(wccdwmpcok) = pwvkasbvls wlmczyludb (scjkhpgsbm, drubmnqrnq - iuhalwjoko) View more
NCT02394730 (ADVICE, Pubmed \| Lancet HIV) Manual	Phase 1/2	Inflammation \| HIV Infections \| Blood Coagulation Disorders	65	vorapaxar	kmomdnzrnu(leoornixpl): difference = -0.02 (95% CI, -0.10 to 0.05), P-Value = 0.56	Positive	01 Oct 2018
				Placebo
NCT00527943 (TRACER, Pubmed \| Am Heart J)	Phase 3	Non ST segment elevation acute coronary syndrome	12,944	Vorapaxar	ouwerccten(doalfyvhfk): HR = 1.12 (95% CI, 0.88 - 1.43), P-Value = 0.435 View more	-	01 Aug 2016
				Placebo

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