PALSONIFY (paltusotine hydrochloride)
Palsonify treats adults with acromegaly who have already tried surgery without success or who are unable to have surgery. It helps patients with this condition by suppressing the secretion of growth hormone and insulin-like growth factor-1. This medication provides a pharmacological option for managing hormone levels when surgical intervention is not effective or possible.
How PALSONIFY Works
This drug works by acting as a selective agonist for somatostatin receptor 2, mimicking the activity of the natural hormone somatostatin. When it binds to these specific receptors, it inhibits the accumulation of cyclic adenosine monophosphate. This process results in the suppression of growth hormone and insulin-like growth factor-1 secretion.
Details
- Status
- Prescription
- First Approved
- 2025-09-25
- Patent Cliff
- 2044
- Routes
- ORAL
- Dosage Forms
- TABLET
PALSONIFY Approval History
What PALSONIFY Treats
1 indicationsPALSONIFY is approved for 1 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Acromegaly
PALSONIFY Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to PALSONIFY
3 of 10FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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.
PALSONIFY FDA Label Details
Indications & Usage
FDA Label (PDF)PALSONIFY is indicated for the treatment of Acromegaly.
PALSONIFY Patents & Exclusivity
Patents (9 active)
Exclusivity
Pro Intelligence Preview
Deep insights for PALSONIFY
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2044
- • 36 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 10 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.