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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, a form of pulmonary arterial hypertension. It is a small molecule delivered via inhalation and is currently in Phase 3 clinical development.
LIQ861 Treprostinil contains treprostinil, a prostacyclin analog that targets prostacyclin receptors to cause vasodilation of pulmonary arteries. This mechanism helps reduce pulmonary arterial pressure in patients with primary pulmonary hypertension. The drug is administered as a dry powder inhalation.
LIQ861 Treprostinil is being developed by Liquidia Corporation, a biopharmaceutical company listed on the NASDAQ under the ticker symbol LQDA. The company is conducting Phase 3 clinical trials to evaluate the safety and efficacy of this inhaled treprostinil formulation for primary pulmonary hypertension.
LIQ861 Treprostinil is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. Two Phase 3 trials have been conducted: one completed and one active but not recruiting, with a combined enrollment of 213 patients.
LIQ861 Treprostinil has two Phase 3 clinical trials. NCT03399604, completed, enrolled 121 patients to investigate safety and pharmacology. NCT03992755, active but not recruiting, enrolled 92 patients for a long-term safety extension study. Both trials are in the United States and include adults aged 18 and older.
Yes, LIQ861 Treprostinil is also known as LIQ861 Inhaled Treprostinil. Both names refer to the same investigational dry powder inhalation formulation of treprostinil being developed by Liquidia Corporation for primary pulmonary hypertension.