Yutrepia FDA Approval History
Last updated by Judith Stewart, BPharm on May 27, 2025.
FDA Approved: Yes (First approved May 23, 2025)
Brand name: Yutrepia
Generic name: treprostinil
Dosage form: Inhalation Powder
Previous Name: LIQ861
Company: Liquidia Technologies, Inc.
Treatment for: Pulmonary Arterial Hypertension; Pulmonary Hypertension Associated with Interstitial Lung Disease
Yutrepia (treprostinil) is an inhaled dry powder formulation of the prostacyclin mimetic treprostinil approved for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease.
- Yutrepia is indicated for the treatment of:
- Pulmonary arterial hypertension (PAH; WHO Group 1) to improve exercise ability. Studies establishing effectiveness predominately included patients with NYHA Functional Class III symptoms and etiologies of idiopathic or heritable PAH (56%) or PAH associated with connective tissue diseases (33%).
- Pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability. The study establishing effectiveness predominately included patients with etiologies of idiopathic interstitial pneumonia (IIP) (45%) inclusive of idiopathic pulmonary fibrosis (IPF), combined pulmonary fibrosis and emphysema (CPFE) (25%), and WHO Group 3 connective tissue disease (22%). - Pulmonary arterial hypertension (PAH) is a rare, chronic, progressive disease caused by narrowing, thickening or stiffening of the pulmonary arteries that can lead to right heart failure and eventually death. Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD) includes pulmonary diseases such as interstitial pulmonary fibrosis, chronic hypersensitivity pneumonitis, connective tissue disease-related ILD, and chronic pulmonary fibrosis with emphysema. Symptoms of PAH or PH-ILD can include shortness of breath, chest pressure, rapid heart rate, and swelling of legs and ankles.
- Yutrepia contains treprostinil, a prostacyclin analog first approved by the FDA in 2002. Treprostinil is approved under multiple brand names and dosage forms including Remodulin (injection), Tyvaso (inhalation solution) and Tyvaso DPI (inhalation powder), and Orenitram (extended-release tablets).
- Yutrepia is a dry-powder formulation of treprostinil containing drug particles that are engineered for enhanced deposition in the lung following oral inhalation.
- FDA approval of Yutrepia was based on findings from the Phase 3 INSPIRE trial which demonstrated safety and tolerability regardless of a patient’s previous exposure to treprostinil.
- Yutrepia inhalation capsules are administered via an inhaler 3 to 5 times per day.
- Warnings and precautions associated with Yutrepia include symptomatic hypotension, an increased risk of bleeding through inhibition of platelet aggregation, and bronchospasm.
- Common adverse reactions (≥10%) include cough, headache, throat irritation, and dizziness.
Development timeline for Yutrepia
Further information
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