Inactive Instrument

VIVUS, Inc.

VVUSQ

US9285513084

VIVUS Announces Enrollment of First Patient in Phase 2 Clinical Trial Assessing Ethanol-Free Carmustine as a Component of High-Dose Chemotherapy Prior to Transplant in Patients with Hodgkin or Non-Hodgkin Lymphoma

Published on 04/14/2025 at 09:00 am EDT

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VIVUS, INC.

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VIVUS LLC announced the first patient has been enrolled in a Phase 2 clinical trial evaluating VI-0609, an innovative ethanol-free formulation of carmustine, as a component of high-dose conditioning chemotherapy in patients with refractory or relapsed Hodgkin or non-Hodgkin lymphoma undergoing autologous hematopoietic cell transplant (AHCT). While the most commonly used conditioning regimen (BEAM) includes carmustine formulated with ethanol, VI-0609 is expected to improve safety of this important chemotherapy agent. The Phase 2 study (NCT06915246) is a randomized multicenter trial designed to evaluate the effects of VI-0609 versus BiCNU in the BEAM high-intensity conditioning regimen for AHCT in subjects with lymphomas.

The primary objectives are to evaluate infusion-related toxicities for VI-0609/BiCNU within 24 hours post infusion and unacceptable toxicities for VI-0609/BiCNU from start of BEAM through Day 30 post-AHCT.

Latest news about VIVUS, Inc.

Jan. 26	VIVUS LLC Announces the Results of a Randomized Trial Evaluating the Effect of QSYMIA	CI
Jan. 07	VIVUS Introduces Lower Pricing on QSYMIA at Costco Locations Across Hawaii	CI
25-09-04	VIVUS Showcases Leadership in Obesity Management at the 2025 International Congress on Obesity and MEtabolic Syndrome	CI
25-05-27	VIVUS Announces Qsymia Now Available at Costco Pharmacies Nationwide	CI
25-04-14	VIVUS Announces Enrollment of First Patient in Phase 2 Clinical Trial Assessing Ethanol-Free Carmustine as a Component of High-Dose Chemotherapy Prior to Transplant in Patients with Hodgkin or Non-Hodgkin Lymphoma	CI
25-03-10	VIVUS Launches QSYMIA in the United Arab Emirates	CI
24-10-23	VIVUS Announces Label Update for QSYMIA	CI
24-05-30	Vivus, Inc. Announces the Publication of New Clinical Trial Data Demonstrating That Pancreaze Helped to Stabilize Weight in Patients Undergoing Chemotherapy for the Treatment of Pancreatic Ductal Adenocarcinoma	CI
24-04-22	VIVUS LLC Announces It Will Provide Telehealth to Patients Through an Enhanced 'Engage' Program in Collaboration with UpScriptHealth	CI
23-11-28	VIVUS LLC Announces Positive Topline Data from a Post-Marketing Study to Evaluate the Effect of QSYMIA	CI
23-01-10	VIVUS, Inc. Promotes Santosh T. Varghese to President VIVUS Global Pharmaceutical Development	CI
22-07-20	FDA Approves VIVUS LLC's QSYMIA® for the Treatment of Obesity in Adolescents Ages 12-17	CI
20-12-10	VIVUS, Inc. Emerged from Bankruptcy	CI
20-12-10	Revised Second Amended Reorganization Plan & Disclosure Statement Approved for VIVUS, Inc.	CI
20-11-16	First Motion for Exclusivity Period Extension Approved For VIVUS, Inc.	CI

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Company Profile

VIVUS, Inc. is a biopharmaceutical company. The Company operates in the development and commercialization of therapeutic products segment. It provides over two therapies approved by the Food and Drug Association (FDA), which include Qsymia (phentermine and topiramate extended-release) for chronic weight management and STENDRA (avanafil) for erectile dysfunction (ED). The Company has completed the Phase II studies of Qsymia for the indication of Obstructive Sleep Apnea (OSA) and diabetes. Its Qsymia is available in over 40,000 certified retail pharmacies across the country. Its STENDRA is also approved by the European Commission (EC), under the name, SPEDRA, for the treatment of ED in the Europe. The United States Food and Drug Association approved a Supplemental New Drug Application (sNDA) for STENDRA. STENDRA is indicated to be taken approximately 15 minutes before sexual activity.

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