TheraRadar
Data updated: May 26, 2026

TRIENTINE HYDROCHLORIDE

Rare Disease Approved 2018-02-07

TRIENTINE HYDROCHLORIDE is indicated for the treatment of Wilson's Disease.

Source: FDA Label • CHARTWELL RX
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
13
Indications
--
Phase 3 Trials
8
Years on Market

Details

Status
Discontinued
First Approved
2018-02-07
Routes
ORAL
Dosage Forms
CAPSULE

Companies

CHARTWELL RX NAVINTA LLC WATSON LABS TEVA ACCORD HLTHCARE Dr. Reddy's MSN ZYDUS PHARMS HETERO LABS LTD III PH HEALTH AMNEAL Lupin ECI PHARMS LLC RISING
Active Ingredient: TRIENTINE HYDROCHLORIDE

TRIENTINE HYDROCHLORIDE Approval History

2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
19 FDA actions from 2018 to 2025
Apr 2025 SUPPL
Label · Labeling
Sep 2023 SUPPL
Mfg · Manufacturing (CMC)
Jun 2022 ORIGINAL
Update

What TRIENTINE HYDROCHLORIDE Treats

1 indications

TRIENTINE HYDROCHLORIDE is approved for 1 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Wilson's Disease
Source: FDA Label

TRIENTINE HYDROCHLORIDE Competitive Set

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

Indication competitors

3

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

CUVRIOR
ORPHALAN
2022 1 indic.
PENICILLAMINE
INVAGEN PHARMS
2019 3 indic.
Unlock 1 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 TRIENTINE HYDROCHLORIDE

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

CUVRIOR
TRIENTINE TETRAHYDROCHLORIDE
1 shared
ORPHALAN
Shared indications:
Wilson's Disease
GALZIN
ZINC ACETATE
1 shared
ETON
Shared indications:
Wilson's Disease
PENICILLAMINE
PENICILLAMINE
1 shared
INVAGEN PHARMS
Shared indications:
Wilson's Disease
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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

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.

TRIENTINE HYDROCHLORIDE FDA Label Details

Indications & Usage

TRIENTINE HYDROCHLORIDE is indicated for the treatment of Wilson's Disease.

Looking for the branded version?

SYPRINE

Full clinical data, patents, trials, and competitive landscape for trientine hydrochloride.

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Data Sources

FDA Approval: ANDA209415 → Label: DailyMed → Trials: ClinicalTrials.gov →

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