Transpire Bio Granted Orphan Drug Designation by the U.S. FDA For Two Rare Diseases

• TRB-ILD1 granted U.S. Orphan Drug Designation by the FDA for the treatment of Idiopathic Pulmonary Fibrosis (IPF)
• TRB-ONC1 granted U.S. Orphan Drug Designation by the FDA for the treatment of glioblastoma (GBM)

SUNRISE, Fla., Oct. 15, 2025 (GLOBE NEWSWIRE) -- Transpire Bio, an integrated, clinical-stage biopharmaceutical company focused on developing inhaled therapeutics for pulmonary and systemic diseases, today announced that the U.S. FDA has granted orphan drug designation (ODD) for two of its products in development.

TRB-ILD1, an inhaled phosphodiesterase-4 (PDE4) inhibitor formulation, received Orphan Drug Designation for the treatment of idiopathic pulmonary fibrosis (IPF).

TRB-ONC1, a novel, synthetic inhaled cannabidiol (CBD) formulation, received Orphan Drug Designation for the treatment of glioblastoma (GBM), an aggressive brain cancer with limited effective therapies.

“Receiving orphan drug designation for both TRB-ILD1 and TRB-ONC1 marks an important milestone in our efforts to bring transformative, inhaled treatment options to people living with rare diseases like idiopathic pulmonary fibrosis and glioblastoma,” said Dr. Xian-Ming Zeng, Chief Executive Officer of Transpire Bio. “Our team in South Florida has extensive expertise in developing inhaled medicines, and we are dedicated to finding new treatment options to help patients living with rare diseases live better lives,” said Mark Lepore, MD, Chief Medical Officer of Transpire Bio.

The FDA’s orphan drug designation program provides incentives to encourage the development of therapies for rare diseases affecting fewer than 200,000 people in the U.S. The designation comes with potential benefits for the sponsor company, including tax credits for qualified clinical trials, exemption from user fees, and a potential seven years of market exclusivity after approval.

About Transpire Bio Inc.
Transpire Bio Inc. is an integrated, US-based, revenue-generating, clinical-stage biopharmaceutical company headquartered in Sunrise, Florida. Transpire Bio harnesses its inhaled drug delivery expertise to improve patients’ lives by expanding access to important therapies and developing treatments for serious diseases where therapeutic options are significantly lacking. Transpire Bio has developed multiple proprietary inhalation technology platforms, including dry powder inhalers and soft-mist inhalers. Transpire Bio is building a pipeline of innovative inhalation medicines for Idiopathic Pulmonary Fibrosis (IPF) where it has three assets in development. Transpire Bio is also developing therapies for Pulmonary Arterial Hypertension (PAH), Diabetes, Obesity, Parkinson's Disease Psychosis, and Glioblastoma.

For more information, please visit www.transpirebio.com

Corporate Inquiries
info@transpirebio.com
+1 954.908.2233

Investor Inquiries
Stuart Loesch
Chief Commercial Officer, Transpire Bio
Stuart.Loesch@transpirebio.com

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