TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

PENTAM

PENTAMIDINE ISETHIONATE
Oncology Approved 1984-10-16
1
Indication
--
Phase 3 Trials
1
Priority Reviews
41
Years on Market

Details

Status
Prescription
First Approved
1984-10-16
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

Active Ingredient: PENTAMIDINE ISETHIONATE

PENTAM Approval History

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What PENTAM Treats

2 indications

PENTAM is approved for 2 conditions since its original approval in 1984. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Pneumocystis jiroveci Pneumonia
  • Kaposi's Sarcoma
Source: FDA Label
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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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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.

PENTAM FDA Label Details

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Indications & Usage

Pentamidine Isethionate is indicated for the prevention of Pneumocystis jiroveci pneumonia (PJP) in high-risk, HIV-infected patients defined by one or both of the following criteria: i. a history of one or more episodes of PJP ii. a peripheral CD4+ (T4 helper/inducer) lymphocyte count less than or equal to 200/mm 3 . These indications are based on the results of an 18-month randomized, dose-response trial in high risk HIV-infected patients and on existing epidemiological data from natural history studies. The patient population of the controlled trial consisted of 408 patients, 237 of whom had...

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Data Sources

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