PRESAMINE (imipramine hydrochloride) · Sanofi
PRESAMINE is FDA-approved to treat 2 conditions (same as IMIPRAMINE HYDROCHLORIDE).
Details
- Status
- Discontinued
- First Approved
- 1959-04-16
- Routes
- ORAL
- Dosage Forms
- TABLET
PRESAMINE Approval History
What PRESAMINE Treats
2 indicationsPRESAMINE is approved for 2 conditions since its original approval in 1959. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Depression
- Enuresis
Same approved indications as IMIPRAMINE HYDROCHLORIDE (same active ingredient).
Sanofi's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04863950 | CTMS# 20-0148 | Ph 2 | recruiting | Investigator-Initiated Study of Imipramine Hydrochloride and Lomustine in Recurrent Glioblastoma |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
PRESAMINE FDA Label Details
Indications & Usage
PRESAMINE is FDA-approved to treat 2 conditions — same approved indications as IMIPRAMINE HYDROCHLORIDE.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.