FDA grants Expanded Access Protocol to RLF-100 (Aviptadil) for Respiratory Failure in COVID-19
RELIEF THERAPEUTICS Holding AG (SIX:RLF, OTC:RLFTF) “Relief” and its U.S. partner, NeuroRx, Inc. today announced that FDA has granted an Expanded Access Protocol for treatment of Respiratory Failure in COVID-19 with RLF-100 (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP). The protocol makes treatment available to patients who have exhausted standard therapies and are not eligible for the current phase 2/3 trial of RLF-100 because of confounding medical conditions and specifically makes the treatment available to pregnant women. Although the drug remains under investigation, rapid recovery from respiratory failure in COVID-19 has been seen in patients treated under FDA Emergency Use authorization.1
The expanded access protocol may be viewed on www.clinicaltrials.gov NCT04453839. Physicians who wish to enroll their patients in the protocol must submit the protocol to their local investigational review board and file FDA form 1572 with NeuroRx, Inc. Further information may be obtained from expandedaccess@neurorxpharma.com.
“By granting this Expanded Access protocol, FDA has made a potentially lifesaving drug immediately available to critically ill patients who have no other available treatment,” said Dr. Jonathan C. Javitt, MD, MPH, NeuroRx’s CEO. “We thank the FDA’s pulmonary division for its rapid and proactive implementation of the Coronavirus Treatment Acceleration Program, and we aspire to demonstrate broad safety and efficacy for RLF-100 in our ongoing clinical trial.”
The SARS-CoV-2 coronavirus that causes COVID-19 attacks the body by entering the small population of Alveolar Type II cells in the lung.2 Without Type II cells, the lung cannot transmit oxygen, which why the coronavirus causes acute respiratory failure. 50 years of scientific research demonstrates that VIP binds specifically to the Type II cell and protects that cell against cytokines (inflammatory molecules) and a wide array of toxic and infectious injuries.”3
About RELIEF THERAPEUTICS Holding AG
The Relief group of companies focus primarily on clinical-stage projects based on molecules of natural origin (peptides and proteins) with a history of clinical testing and use in human patients or a strong scientific rational. Currently, Relief is concentrating its efforts on developing new treatments for respiratory disease indications.
Relief Therapeutics holds orphan drug designations from the U.S. Food and Drug Administration and the European Union for the use of VIP to treat ARDS, pulmonary hypertension, and sarcoidosis. Relief Therapeutics also holds a U.S. patent4 for RLF-100 and proprietary manufacturing processes for its synthesis.
RELIEF THERAPEUTICS Holding AG is listed on the SIX Swiss Exchange under the symbol RLF (ISIN: CH0100191136).
About NeuroRx, Inc.
NeuroRx draws upon more than 100 years of collective drug development experience and is led by former senior executives of Johnson & Johnson, Eli Lilly, Pfizer, and AstraZeneca, PPD. In addition to its work on RLF-100, NeuroRx has been awarded Breakthrough Therapy Designation and a Special Protocol Agreement to develop NRX-101 for the treatment of suicidal bipolar depression and is currently in Phase 3 trials.
Disclaimer: This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding AG, NeuroRx, Inc. and their businesses. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding AG and/or NeuroRx, Inc. to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.
1 Youssef JG, Rapid Clinical Recovery from Critical COVID-19 with Respiratory Failure in a Lung Transplant Patient Treated with Intravenous Vasoactive Intestinal Peptide doi: 10.20944/preprints202007.0178.v1
2 Mason R. Pathogenesis of COVID-19 from a Cell Biologic Perspective. Eur Respir J. April 9 Epub ahead of print. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7144II60/
4 US 8,178,489 Formulation for Aviptadil
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200728005828/en/
Contact information
CORPORATE CONTACTS
US Inquiries
Jonathan C. Javitt, M.D., MPH
Chief Executive Officer
NeuroRx, Inc.
ceo@neurorxpharma.com
European Inquiries:
Yves Sagot, Ph.D.
Relief Therapeutics Holding, SA
yves.sagot@relieftherapeutics.com
MEDIA CONTACT
David Schull
Russo Partners, LLC
david.schull@russopartnersllc.com
858-717-2310
INVESTOR RELATIONS
Brian Korb
Solebury Trout
bkorb@troutgroup.com
917-653-5122
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
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
Most Delivered Light-Entry Jet Cessna Citation M2 Gen2 With Garmin Autothrottles Enters Into Service, Bringing Greater Control and Precision to Pilots14.1.2026 21:30:00 EET | Press release
The Cessna Citation M2 Gen2 with Garmin Autothrottles recently entered into service. Certified by the Federal Aviation Administration in October 2025, the integration of Garmin’s Autothrottle system in the Citation M2 Gen2 further supports the most delivered light-entry jet’s capabilities by bringing greater control and precision to pilots. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260114646844/en/ Most delivered light-entry jet Cessna Citation M2 Gen2 with Garmin Autothrottles enters into service, bringing greater control and precision to pilots (Photo Credit: Textron Aviation). The Cessna Citation M2 Gen2 is designed and manufactured by Textron Aviation Inc., a Textron Inc. (NYSE: TXT) company. “We continue to invest in our products to provide customers with the best aviation experience in the world," said Lannie O’Bannion, senior vice president, Sales & Marketing. “The M2 Gen2 leads its segment as the most delivered
TwentyTwo Real Estate and Farallon Capital Complete €761 Million Investment in Isemia, a €1.2bn Healthcare Real Estate Company Created With emeis14.1.2026 19:30:00 EET | Press release
TwentyTwo Real Estate, an independent European real estate investment and management firm, announces the completion, alongside Farallon Capital, of a €761 million investment that led to the creation of Isemia (www.isemiabyemeis.com), a leading healthcare real estate company holding a €1.2 billion portfolio of assets operated by emeis. The transaction represents a significant milestone in TwentyTwo Real Estate’s long-term investment strategy focused on healthcare and operational living real estate. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260114262830/en/ Fachklinik Schömberg Isemia comprises 68 high-quality assets across France, Germany and Spain, with a balanced mix of nursing homes (48%) and clinics (52%). The portfolio benefits from strong fundamentals and resilient operating performance. All properties will continue to be operated by emeis under long-term lease agreements, ensuring continuity of care for residents
AI’s Water Demand to Surge Nearly 130% by 2050 – New Research Shows How to Build a Water-Secure AI Economy14.1.2026 17:00:00 EET | Press release
The rapid global expansion of artificial intelligence is set to drive a 129% increase in water demand across the AI value chain by 2050, according to new research by Xylem (NYSE: XYL) and Global Water Intelligence (GWI). Watering the New Economy: Managing the Impacts of the AI Revolution provides the most comprehensive assessment to date of how AI is reshaping global water use. It also highlights practical ways to meet that demand while strengthening water security for communities. Spending on AI is forecast to approach $2 trillion in 2026,1 accelerating infrastructure build-out worldwide. By the middle of the century, this expansion is projected to add 30 trillion liters of water demand, annually, fueled by a surge in power generation (~54% of the increase), semiconductor fabrication (~42%), and data center expansion (~4%). Crucially, the report finds that this additional demand does not have to result in competition between industry and communities. Today, global water systems proces
Primient to Acquire Full Ownership of Primient Covation, LLC14.1.2026 17:00:00 EET | Press release
Primient, a global leader in biomanufacturing, announced today it has agreed to purchase the remaining ownership interest in Primient Covation, LLC (“Primient Covation”), establishing Primient as the sole owner of the company and marking an exciting new chapter in Primient’s growth in the bioeconomy. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260114344080/en/ This acquisition is the next step of Primient’s strategy to strengthen Primient’s leadership position in biomanufacturing and builds upon recent announcements, including Primient’s partnership with Sustainea and the creation of the iPROOF venture. Primient Covation stands as a leading force in the U.S. biomanufacturing sector, distinguished by its broad range of biomanufacturing and fermentation expertise. The company was founded in 2000 to supply a variety of end markets, including cosmetics and personal care, textiles, fashion, coatings, functional fluids, and oth
ACCELQ Crowned Leader and Customer Favorite in The Forrester Wave™ for Autonomous Testing Platforms14.1.2026 17:00:00 EET | Press release
Forrester has named ACCELQ a Leader in The Forrester Wave™: Autonomous Testing Platforms, Q4 2025. This marks the third consecutive Wave in which ACCELQ has been recognized as a Leader. Notably, this evaluation placed strong emphasis on generative AI innovation and real-world customer adoption. ACCELQ received the highest scores for both capabilities and vision and was the only platform to be recognized as a Customer Favorite, earning a "double halo" for exceptional customer endorsement. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260113112861/en/ ACCELQ recognized as a Leader and Customer Favorite in The Forrester Wave™️: Autonomous Testing Platforms, Q4 2025, validating its agentic, GenAI-embedded testing vision. According to the Forrester report, ACCELQ received the highest score among all evaluated vendors in the Current Offering category. Analysts praised the platform’s "impressive vision and innovation," specificall
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