TheraRadar
Data updated: Mar 29, 2026

PIZENSY

LACTITOL
Approved 2020-02-12
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
6
Years on Market

Details

Status
Prescription
First Approved
2020-02-12
Routes
ORAL
Dosage Forms
SOLUTION, FOR SOLUTION

Companies

BRAINTREE LABS
Active Ingredient: LACTITOL

PIZENSY Approval History

Loading approval history...

What PIZENSY Treats

1 FDA approvals

Originally approved for its first indication in 2020 .

  • Other (1)
🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

Loading...
⭐

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

Loading...
📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

|
Loading...
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.

PIZENSY FDA Label Details

Pro

PIZENSY Patents & Exclusivity

Latest Patent: May 2037

Patents (2 active)

US10806743 Expires May 12, 2037
Source: FDA Orange Book

Want competitive intelligence?

See who's developing similar drugs and track their progress

View Pipeline Dashboard

Data Sources

FDA Approval: NDA211281 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.