Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ARN-75039 · 1 trial · 1 indication
A treatment-emergent adverse event (TEAE) was defined as any adverse event that began or worsened after administration of the study drug (ARN-75039 or placebo) through the End-of-Study visit.
Number of participants with at least one treatment-emergent Serious adverse event (TESAE). A TESAE is any adverse event that starts or worsens after administration of study drug (ARN-75039 or placebo).
| Arm | Type | Description |
|---|---|---|
| ARN-75039 oral capsules | EXPERIMENTAL | Escalating single or multiple doses of ARN-75039 oral capsules |
| Placebo (microcrystalline cellulose) | PLACEBO_COMPARATOR | Specified weight of placebo (microcrystalline cellulose) corresponding to the dose of ARN-75039 within the same cohort and encapsulating it in a HPMC capsule prior to dosing. |
| Name | Type | Description |
|---|---|---|
| ARN-75039 oral capsules | DRUG | active oral study drug prepared and administered as oral capsules |
| Placebo | DRUG | Given at frequency and amounts matching ARN- 75039 dosing regimen |
Inclusion Criteria: 1. Is male or female, age 18 to 55 years, inclusive, at Screening. 2. Body mass index (BMI) between 18.5 and 35 kg/m2, inclusive, at Screening. 3. In good general health, determined by no clinically significant findings in the opinion of the Investigator from medical history, ph...
ARN-75039 is an investigational small molecule being studied for use in healthy adult participants. It is currently in Phase 1 clinical development, with a completed trial assessing its safety, tolerability, and pharmacokinetics in healthy subjects.
ARN-75039 is being developed by United Therapeutics Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol UTHR.
ARN-75039 is in Phase 1 clinical development. The single trial for this drug, NCT05735249, has been completed, and the drug remains investigational and is not approved for any use.
ARN-75039 has one completed Phase 1 clinical trial, NCT05735249, titled "A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Oral ARN-75039 in Healthy Adult Subjects." The trial enrolled 94 participants in the United States.
ARN-75039 is not FDA approved. It is an investigational drug that has completed a Phase 1 trial in healthy volunteers, but it is still in clinical development and has not been approved for any medical use.