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Also known as LIQ861 Inhaled Treprostinil
LIQ861 Treprostinil · 2 trials · 1 indication
Treatment-emergent adverse events and serious adverse events will be grouped by MedDRA System Organ Class, dose level at onset, time on drug at onset, and relationship to dose titration.
There were two treatment arms analyzed for events in the study. All subjects that participated in the PK study were part of the transition group and not analyzed separately for adverse events. Treatment-Emergent Adverse Events and Serious Adverse Events will be grouped by MedDRA System Organ Class, dose level, time on drug, and relationship to dose titration
| Arm | Type | Description |
|---|---|---|
| LIQ861 Inhaled Treprostinil | EXPERIMENTAL | LIQ861 inhaled treprostinil at capsule strengths of 25 μg, 50 μg, 75 μg and 100 μg. LIQ861 will be administered using the RS00 Model 8 dry powder inhalation (DPI) device (Plastiape S.p.A.; Osnago, Italy) at dose levels of 25 μg capsule strength to 200 μg capsule strength treprostinil four times a day (QID) in individual patients. Titrating to dose levels beyond 200 μg capsule strength QID, under clinical investigator supervision, requires review and approval from the Medical Monitor. |
| Name | Type | Description |
|---|---|---|
| LIQ861 Inhaled Treprostinil | DRUG | LIQ861 bulk powder is generated from a treprostinil/excipient matrix from which particles of precise size and shape are created and filled into a hydroxypropyl methylcellulose (HPMC) capsule (size 3). LIQ861 capsules are provided in capsule strengths of 25 μg, 50 μg, 75 μg and 100 μg treprostinil. |
Inclusion Criteria: 1. Evidence of a personally signed and dated informed consent document exists indicating that the patient has been informed of all pertinent aspects of the study prior to initiation of any study-related procedures. 2. Patient is willing and able to comply with scheduled visits, ...
LIQ861 Treprostinil is an investigational dry powder inhalation of treprostinil being developed for the treatment of Primary Pulmonary Hypertension. It is a small molecule prostacyclin analog delivered via inhalation. The drug is currently in Phase 3 clinical development and is not yet approved by the FDA.
LIQ861 Treprostinil targets the prostacyclin pathway. As a prostacyclin analog, it is designed to mimic the action of prostacyclin, a naturally occurring molecule that dilates blood vessels and inhibits platelet aggregation. This mechanism is relevant for treating Primary Pulmonary Hypertension by potentially reducing pulmonary arterial pressure.
LIQ861 Treprostinil is being developed by Liquidia Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol LQDA. The company is advancing this inhaled treprostinil formulation through clinical trials for the treatment of Primary Pulmonary Hypertension.
LIQ861 Treprostinil is in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by the FDA for commercial use. The drug is being studied for the treatment of Primary Pulmonary Hypertension, with clinical trials ongoing to evaluate its safety and pharmacology.
LIQ861 Treprostinil has been studied in two Phase 3 clinical trials. NCT03399604, a completed trial with 121 participants, investigated the safety and pharmacology of dry powder inhalation of treprostinil. NCT03992755, an active but not recruiting extension study with 92 participants, evaluates long-term safety. Both trials enrolled adults with Primary Pulmonary Hypertension in the United States.
Yes, LIQ861 Treprostinil is also known as LIQ861 Inhaled Treprostinil. Both names refer to the same investigational drug product being developed by Liquidia Corporation for the treatment of Primary Pulmonary Hypertension. The drug is administered as a dry powder inhalation formulation of treprostinil.