Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PL3994 · 1 trial · 1 indication
The pharmacokinetic profile parameters for PL-3994 were calculated using a non compartmental approach. •Maximum concentration (Cmax) The subject numbers below are the evaluable subjects only. The Evaluable Subjects population consisted of subjects who received study drug and who had no major protocol deviations that would have excluded the subject from analysis, and for whom calculations of PK parameters were possible.
Pharmacodynamic parameters were calculated from the baseline-adjusted plasma cGMP level-time data using WinNonlin® 5.0.1. Actual sample times were used in the calculations. Baseline was the pre-dose levels of plasma cGMP at Visit 2 (Day 1): Emax The patient numbers below represent the evaluable subjects only. The Evaluable Subjects population consisted of subjects who received study drug and who had no major protocol deviations that would have excluded the subject from analysis, and for whom calculations of PD parameters were possible.
| Arm | Type | Description |
|---|---|---|
| PL3994 Dose A | EXPERIMENTAL | PL3994 Dose A |
| PL3994 Dose B | EXPERIMENTAL | PL3994 Dose B |
| PL3994 Dose C | EXPERIMENTAL | PL3994 Dose C |
| PL3994 Dose D | EXPERIMENTAL | PL3994 Dose D |
| PL3994 Dose E | EXPERIMENTAL | PL3994 Dose E |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| PL3994 | DRUG | Study drug |
| Placebo | DRUG | Placebo |
Inclusion Criteria: * Subjects must have had a diagnosis of essential hypertension for at least 1 year, per subject verbal history * Subject must be on a stable dose of at least one, but not more than 3 antihypertensive medications for at least 3 months, per subject verbal history. * Subject must h...
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PL3994 is being developed for the treatment of hypertension. It is a small molecule therapeutic candidate from Palatin Technologies, Inc. that has been studied in a Phase 2 clinical trial in subjects with controlled hypertension. It is investigational and has not been approved for any indication.
PL3994 targets NPR-A, the natriuretic peptide receptor A. NPR-A is part of the natriuretic peptide receptor class. By acting on this receptor, PL3994 is designed to influence cardiovascular signaling relevant to blood pressure regulation. The drug is a small molecule developed by Palatin Technologies.
PL3994 is being developed by Palatin Technologies, Inc., which trades under the ticker PTN. The company is the sponsor of the clinical program for this hypertension candidate.
PL3994 is in Phase 2 clinical development. It has completed one Phase 2 trial in hypertension. The drug is investigational and has not been approved by the FDA or any regulatory authority for marketing.
PL3994 has been studied in one completed Phase 2 trial, NCT00686803, titled "Safety Study of Subcutaneously Administered PL-3994 in Subjects With Controlled Hypertension." The trial enrolled 21 participants, was randomized, double-blind, and placebo-controlled, and included adults 18 years and older of all sexes.