PENTAMIDINE ISETHIONATE · PAI HOLDINGS PHARM
Pentamidine isethionate is indicated for the prevention of *Pneumocystis jiroveci* pneumonia (PJP) in high-risk, HIV-infected patients. High-risk individuals are defined as those with a history of one or more episodes of PJP and/or a peripheral CD4+ (T4 helper/inducer) lymphocyte count less than or equal to 200/mm³. For this preventative indication, the medication is administered via inhalation using a compatible nebulizer system.
How PENTAMIDINE ISETHIONATE Works
The exact mechanism of action of pentamidine isethionate is not fully understood. However, studies suggest the drug interferes with microbial nuclear metabolism by inhibiting the synthesis of DNA, RNA, phospholipids, and proteins.
Details
- Status
- Prescription
- First Approved
- 1984-10-16
- Routes
- INHALATION, INJECTION
- Dosage Forms
- FOR SOLUTION, INJECTABLE
PENTAMIDINE ISETHIONATE Approval History
What PENTAMIDINE ISETHIONATE Treats
2 indicationsPENTAMIDINE ISETHIONATE is approved for 2 conditions since its original approval in 1992. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Pneumocystis jiroveci Pneumonia
- Kaposi's Sarcoma
PENTAMIDINE ISETHIONATE 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.
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Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07463040 | MAMS4CL | Ph 3 | not yet recruiting | Study Comparing Several Drugs to Understand Which Work Against Cutaneous Leishmaniasis (CL) |
| NCT03403621 results posted | 17-005230 | Ph 1, Ph 2 | terminated | Hypertrophic Scar Prevention by Novel Topical Gel Application |
| NCT03096457 | ABF-BO-2016-102 | Ph 2, Ph 3 | completed | Topical Paromomycin for Cutaneous Leishmaniasis in Bolivia |
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.
PENTAMIDINE ISETHIONATE FDA Label Details
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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Full clinical data, patents, trials, and competitive landscape for pentamidine isethionate.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.