Ardent Pharma

Products

The following table summarizes our development programs and their development status.

Program
Ardent Compound
Status
Analgesia
Acute
DPI-3290 i.v.1
Phase 2
DPI-125 i.v.
IND Preparation
Chronic
DPI-32902
Phase 1
Urinary Incontinence
DPI-221
IND Preparation
Premature Ejaculation
TBD3
Lead Selection
Depression
TBD3
Lead Selection
Cardioprotection
TBD3
Lead Selection
  1. Licensed to Organon where it is designated as ORG-41793.
  2. For clinical development studies in chronic pain we will choose either DPI-3290 or DPI-125.
  3. TBD = to be determined.

“Lead Selection” refers to selection of a single molecule from a small number of agents with demonstrated activity in appropriate animal models for the target symptom or disease state. Lead molecules are those that are selected for IND submission.

“IND Preparation” refers to the preparation of an Investigational New Drug application, the process by which a drug is submitted to the Food and Drug Administration to receive approval for human testing. This means a lead molecule is selected, the basic pharmacology is completed, and the toxicology required for human testing is ongoing or completed. Human testing is expected to occur within one year.

“Phase 1″ refers to the stage in which compounds are tested for safety, maximal tolerated dose, and pharmacokinetics in normal volunteers.

“Phase 2″ refers to the initial stages of compound testing in patients with the disease or symptoms of interest for ultimate NDA approval and labeling. This stage first demonstrates the compound’s efficacy and dosing range, and expands the safety profile.

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