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...
PL3994 is an investigational small molecule being developed for the treatment of hypertension, a cardiovascular condition characterized by elevated blood pressure. It is administered subcutaneously and is currently in clinical development, though it is not yet approved for any use.
PL3994 is being developed by Palatin Technologies, Inc., a biopharmaceutical company traded on the NYSE American under the ticker symbol PTN. The company is conducting clinical trials to evaluate the safety and efficacy of PL3994 in patients with hypertension.
PL3994 is in Phase 2 clinical development. A Phase 2 study has been completed, which evaluated the safety of subcutaneously administered PL-3994 in subjects with controlled hypertension. The drug remains investigational and has not received regulatory approval.
PL3994 has one completed Phase 2 clinical trial, identified as NCT00686803. This randomized, double-blind, placebo-controlled study enrolled 21 participants with hypertension to assess the safety of subcutaneously administered PL-3994. The trial included adults aged 18 years and older.
Yes, PL3994 and PL-3994 refer to the same investigational drug. The clinical trial record for this compound uses the name PL-3994, while the drug is also referred to as PL3994 in development documentation. Both names denote the same small molecule being studied for hypertension.