TheraRadar
Data updated: May 26, 2026

PAROMOMYCIN SULFATE

Infectious Disease Approved 1997-06-30

PAROMOMYCIN SULFATE is indicated for the treatment of Amebiasis; Hepatic Coma.

Source: FDA Label • Sun Pharma
2
Indications
--
Phase 3 Trials
28
Years on Market

Details

Status
Discontinued
First Approved
1997-06-30
Routes
ORAL
Dosage Forms
CAPSULE

Companies

Active Ingredient: PAROMOMYCIN SULFATE

PAROMOMYCIN SULFATE Approval History

1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
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2018
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2020
2021
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2024
2025
2026
Original
New Indication
New Form
Label Update
4 FDA actions from 1997 to 2015
Oct 2015 SUPPL
Mfg · Manufacturing (CMC)
Dec 2007 ORIGINAL
Update
Jun 1997 ORIGINAL
Update

What PAROMOMYCIN SULFATE Treats

2 indications

PAROMOMYCIN SULFATE is approved for 2 conditions since its original approval in 1997. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Amebiasis
  • Hepatic Coma
Source: FDA Label

PAROMOMYCIN SULFATE Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

2

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 PAROMOMYCIN SULFATE

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

LIKMEZ
METRONIDAZOLE
1 shared
SAPTALIS PHARMS
Shared indications:
Amebiasis
TINDAMAX
TINIDAZOLE
1 shared
MISSION PHARMA
Shared indications:
Amebiasis
📋

Clinical Trial Registry

1 trials
Trial Sponsor ID Phase Status Title
NCT03096457 ABF-BO-2016-102 Ph 2, Ph 3 completed Topical Paromomycin for Cutaneous Leishmaniasis in Bolivia
🔬

Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

Pro

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.

PAROMOMYCIN SULFATE FDA Label Details

Indications & Usage

PAROMOMYCIN SULFATE is indicated for the treatment of Amebiasis; Hepatic Coma.

Looking for the branded version?

HUMATIN

Full clinical data, patents, trials, and competitive landscape for paromomycin sulfate.

See HUMATIN

Data Sources

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