BOEHRINGER-INGELHEIM
Boehringer Ingelheim and Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078) today announced that the US Food and Drug Administration (FDA) has granted Fast Track Designation to the GLP-1/glucagon dual agonist BI 456906 for adults with non-alcoholic steatohepatitis (NASH). The Fast Track Designation facilitates the development and expedites the review of new therapies to treat serious conditions and fill an unmet medical need. BI 456906 is currently being evaluated in a Phase II study in adults with NASH and liver fibrosis (F2/F3) with and without diabetes.
“The FDA Fast Track Designation for our dual agonist is an important step forward in addressing the high unmet medical need among the up to 444 million adults estimated to be living with NASH,” said Waheed Jamal, MD, Corporate Vice President and Head of CardioMetabolic Medicine, Boehringer Ingelheim. “Together with our partner Zealand Pharma, we look forward to working closely with the FDA as we explore the potential of the GLP-1/glucagon agonist to improve outcomes for adults with NASH.”
“Boehringer Ingelheim and Zealand Pharma are committed to delivering innovative solutions that address public health challenges of cardiometabolic diseases, including NASH,” said Adam Steensberg, Executive Vice President and Chief Medical Officer at Zealand Pharma. “By combining Boehringer Ingelheim’s expertise in drug development in the cardio-metabolic area with our strength in the discovery of innovative peptide-based medicines, we have the potential to bring forward a novel therapy option in an area with limited available treatments.”
The GLP-1/glucagon compound derived from the natural gut hormone oxyntomodulin activates both the GLP-1 and glucagon receptors that are critical to controlling metabolic functions. The dual agonist BI 456906 has the potential to be a new, once-weekly treatment that may offer therapeutically relevant benefits compared to currently available treatments. It is also being investigated as a potential treatment option for adults living with diabetes and for adults living with obesity. It is part of Boehringer Ingelheim’s research and development portfolio in the cardiometabolic disease areas.
Please click on the following link for ‘Notes to Editors’:
http://www.boehringer-ingelheim.com/press-release/fast-track-designation-nash
View source version on businesswire.com: https://www.businesswire.com/news/home/20210602005582/en/
Link:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Copeland Expands Industrial Heat Pump Portfolio with Agreement to Acquire SPH Sustainable Process Heat23.10.2025 22:30:00 CEST | Press release
Acquisition enhances Copeland’s industrial heating portfolio Copeland, a global leader in sustainable climate solutions, today announced its agreement to acquire SPH Sustainable Process Heat (SPH), a Germany-based industrial heat pump technology company. This acquisition is expected to expand Copeland’s industrial heating portfolio, allowing the company to deliver a broader range of key heat pump technologies and solutions to new and existing customers. Copeland’s industrial business operates under the brand name Vilter. SPH will continue to operate independently until closing. This acquisition reinforces Copeland’s commitment to enabling the energy transition, in this case, through innovative technologies that enable industrial customers to replace fossil-fuel systems with more energy-efficient heating alternatives. SPH brings a strong technology portfolio, including its innovative ThermBooster™ technology, and demonstrated capability in delivering solutions to a broad range of indust
NIQ Publishes 2025 ESG Progress Report: Advancing Integrity, Innovation, and Impact23.10.2025 22:05:00 CEST | Press release
NIQ (NYSE: NIQ), a leading consumer intelligence company, today released its 2025 Environmental, Social, and Governance (ESG) Progress Report, covering its progress in 2024 and underscoring the company’s commitment to responsible business, data integrity, and inclusive growth across its global operations. “As a leading consumer intelligence company, our responsibility extends far beyond the industries we serve,” said Jim Peck, Executive Chairman and CEO of NIQ. “This year’s ESG Progress Report demonstrates how we are embedding sustainable and inclusive principles into our business, driving value for our clients, investors, associates, and communities.” Key progress areas from 2024Strengthened ESG governance: NIQ formalized its internal ESG governance framework and initiated a Double Materiality Assessment, aligning with the latest global standards and regulations. Advanced data integrity and security: The company advanced its use of AI and machine learning to ensure data quality, priva
Andersen Consulting udvider sine digitale transformationskompetencer med MOYO23.10.2025 19:47:00 CEST | Pressemeddelelse
Andersen Consulting fortsætter med at styrke sine transformationskompetencer inden for teknologi og forretning via en samarbejdsaftale med MOYO, der er et digitalt konsulenthus, som leverer integrerede løsninger inden for strategi, data, teknologi, programmering og talentudvikling. MOYO, der blev grundlagt i 2007 af administrerende direktør Pierre le Roux, kombinerer tjenester inden for rådgivning, teknologi og humankapital-tjenester for at hjælpe en bred kundebase – fra startups til store virksomheder inden for finansielle tjenester, minedrift og detailhandel – med at implementere skalerbare systemer, optimere processer og levere skræddersyede løsninger, der udnytter nye muligheder i den digitale økonomi. "Hos MOYO mener vi, at digital transformation kun lykkes, når løsninger skabes med dyb empati og en klar forståelse for menneskene bag virksomheden," sagde Pierre. "Vores samarbejde med Andersen Consulting afspejler det samme engagement i at skabe meningsfulde, langsigtede forandring
Berry Consultants Releases FACTS 8 Clinical Trial Simulator23.10.2025 19:00:00 CEST | Press release
FACTS 8 introduces support for Ordinal endpoints and a new “Quick Start” feature Berry Consultants, LLC announced the release of FACTS 8, the latest version of its industry-leading Fixed and Adaptive Clinical Trial Simulator (FACTS). FACTS 8 is now available to both existing users and new clients worldwide. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251023501254/en/ FACTS is the most powerful, flexible, and efficient platform for designing and simulating clinical trials across the full spectrum of drug development — from early Phase I studies to complex, multi-arm platform trials. The new release introduces two major advancements: Full simulation of ordinal endpoints in Phase II and Phase III trial designs, enabling powerful designs with frequentist and Bayesian methods of analysis. A Quick Start feature that streamlines setup for fixed and group sequential trials while maintaining the full simulation power FACTS provide
Saudi Arabia to Host 26th UN Tourism General Assembly in November Marking Agency’s 50th Year23.10.2025 16:58:00 CEST | Press release
The Kingdom of Saudi Arabia will host the 26th session of the UN Tourism General Assembly from November 7 to 11. The landmark session will focus on “AI-Powered Tourism: Redefining the Future” and also commemorate five decades of cooperation under the United Nations’ specialized agency for tourism. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251022579574/en/ Riyadh Nighttime View Represented by its Ministry of Tourism, Saudi Arabia will welcome more than 160 member states, international organizations, and global industry players to engage in dialogue aimed at securing a brighter, more sustainable future for the industry and shaping the next 50 years of global tourism. Saudi Arabia’s Minister of Tourism, H.E. Ahmed Al Khateeb, invited the world to Riyadh to take part in a momentous milestone for global tourism diplomacy: “We look forward to hosting the world’s leading organization for tourism in a session that will redefine
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom