TheraRadar
Data updated: May 26, 2026

PANRETIN (alitretinoin)

Trial Activity: Declining
Oncology Approved 1999-02-02

PANRETIN is indicated for the treatment of Kaposi's Sarcoma.

Source: FDA Label • ADVANZ PHARMA • Retinoid
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How PANRETIN Works

This medication works by binding to and activating all known subtypes of intracellular retinoid receptors. These activated receptors function as transcription factors that regulate gene expression related to cell growth and development. By controlling these processes, the drug inhibits the proliferation of Kaposi’s sarcoma cells.

Source: FDA Label

Development Insights

Stiefel, a GSK Company conducting 2 trials (40%)
5 indications explored (Moderate)
→ eczema (1 trials)
→ psoriasis (1 trials)
→ lupus erythematosus, cutaneous (1 trials)
1
Indication
--
Phase 3 Trials
1
Priority Reviews
27
Years on Market

Details

Status
Prescription
First Approved
1999-02-02
Routes
TOPICAL
Dosage Forms
GEL

Companies

ADVANZ PHARMA
Active Ingredient: ALITRETINOIN

PANRETIN Approval History

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 1999 to 2025
Nov 2025 SUPPL
Label · Labeling
FDA Letter Label
Nov 2013 SUPPL
Mfg · Manufacturing (CMC)
Nov 2000 SUPPL
Mfg · Manufacturing (CMC)

What PANRETIN Treats

1 indications

PANRETIN is approved for 1 conditions since its original approval in 1999. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Kaposi's Sarcoma
Source: FDA Label

PANRETIN Competitive Set

Pro

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

MoA expansion candidates

5

Same target(s), different indications — where else is this mechanism being explored?

ARAZLO
BAUSCH
2019 1 indic.
DUOBRII
BAUSCH
2019 1 indic.

Indication competitors

2

Same indication, different mechanism — what else might this patient receive?

PENTAMIDINE ISETHIONATE
PAI HOLDINGS
1992 2 indic.
PENTAM
Fresenius Kabi
1984 2 indic.
Unlock 3 more competitors across all three rings.
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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 PANRETIN

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

PENTAM
PENTAMIDINE ISETHIONATE
1 shared
Fresenius Kabi
Shared indications:
Kaposi's Sarcoma
PENTAMIDINE ISETHIONATE
PENTAMIDINE ISETHIONATE
1 shared
PAI HOLDINGS
Shared indications:
Kaposi's Sarcoma
📋

Clinical Trial Registry

5 trials
Trial Sponsor ID Phase Status Title
NCT00817063 HANDEL results posted 117183 BAP01346, NCT00817063 Ph 3 completed Efficacy and Safety of a Retinoid in the Treatment of Severe Chronic Hand Eczema
NCT01245140 results posted 117221 2010-022843-39, BAP02028 Ph 2 completed Efficacy of Alitretinoin Treatment in Patients With Pustular Form of Psoriasis
NCT01407679 AliCLE UKM 10_0019 Ph 2 terminated Efficacy and Safety of Oral Alitretinoin (Toctino®) in the Treatment of Patients With Cutaneous Lupus Erythematosus
NCT01231854 TocyDD TUD-TOCYDD-044 2009-017520-88 Ph 4 terminated Ciclosporin Versus Alitretinoin for Severe Atopic Hand Dermatitis.
NCT01261923 Eudra CT 2010-020212-11 Ph 1, Ph 2 completed Pharmacokinetics of 9-cis-retinoic Acid (Alitretinoin, Toctino®) in Patients With Hepatic Disease
🔬

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

ClinicalTrials.gov ↗ Pro

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.

PANRETIN FDA Label Details

Indications & Usage

FDA Label (PDF)

PANRETIN is indicated for the treatment of Kaposi's Sarcoma.

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Data Sources

FDA Approval: NDA020886 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment