TheraRadar
Data updated: May 26, 2026

SCLEROSOL (talc)

Dermatology Approved 1997-12-24

SCLEROSOL is indicated for the treatment of Tinea Pedis; Tinea Corporis.

Source: FDA Label • SCIARRA LABS
1
Indication
--
Phase 3 Trials
1
Priority Reviews
28
Years on Market

Details

Status
Prescription
First Approved
1997-12-24
Routes
INTRAPLEURAL
Dosage Forms
AEROSOL

Companies

Active Ingredient: TALC

SCLEROSOL Approval History

1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
5 FDA actions from 1997 to 2012
Oct 2012 SUPPL Priority
Mfg · Manufacturing (CMC)
Feb 2001 SUPPL Priority
Mfg · Manufacturing (CMC)
Feb 2000 SUPPL
Label · Labeling

What SCLEROSOL Treats

2 indications

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

  • Tinea Pedis
  • Tinea Corporis
Source: FDA Label

SCLEROSOL Competitive Set

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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 SCLEROSOL

3 of 17

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

CLOTIC
CLOTRIMAZOLE
2 shared
CARWIN PHARM ASSOC
Shared indications:
CLOTRIMAZOLE
CLOTRIMAZOLE
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Hikma
Shared indications:
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
BETAMETHASONE DIPROPIONATE
2 shared
GLENMARK SPECLT
Shared indications:
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Clinical Trial Registry

2 trials
Trial Sponsor ID Phase Status Title
NCT04792970 results posted Pro00107258 Ph 4 terminated Randomized Controlled Trial of Talc Instillation In Addition To Daily Drainage Through a Tunneled Pleural Catheter to Improve Rates of Outpatient Pleurodesis in Patients With Malignant Pleural Effusion
NCT02674243 03315 Ph 3 completed Efficacy of Iodopovidone Versus Talc in Palliative Malignant Pleural Effusion
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Active Pipeline

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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.

SCLEROSOL FDA Label Details

Indications & Usage

FDA Label (PDF)

SCLEROSOL is indicated for the treatment of Tinea Pedis; Tinea Corporis.

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Data Sources

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