TheraRadar
Data updated: May 26, 2026

TRIPTODUR KIT (triptorelin pamoate)

Trial Activity: Stable 1 active trials
Oncology Approved 2017-06-29

TRIPTODUR KIT is indicated for the treatment of Prostate Cancer.

Source: FDA Label • AZURITY

How TRIPTODUR KIT Works

Triptorelin is a synthetic decapeptide agonist analog of endogenous gonadotropin-releasing hormone (GnRH) with greater potency. Initially, triptorelin stimulates the pituitary gland to release luteinizing hormone (LH) and follicle-stimulating hormone (FSH). However, chronic administration leads to the downregulation of pituitary GnRH receptors and desensitization of pituitary gonadotropes. This results in a sustained suppression of LH and FSH secretion, subsequently reducing serum concentrations of gonadal steroids (testosterone in males and estradiol in females) to prepubertal levels.

Development Insights

Children's Oncology Group conducting 1 trials (25%)
5 indications explored (Moderate)
hematopoietic and lymphatic system neoplasm (1 trials)
malignant solid neoplasm (1 trials)
central precocious puberty (1 trials)
1
Indication
--
Phase 3 Trials
8
Years on Market

Details

Status
Prescription
First Approved
2017-06-29
Patent Cliff
2029

Pro Metrics

Patent cliff and revenue data

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Routes
INTRAMUSCULAR
Dosage Forms
FOR SUSPENSION, EXTENDED RELEASE

Companies

Active Ingredient: TRIPTORELIN PAMOATE

TRIPTODUR KIT Approval History

2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
5 FDA actions from 2017 to 2025
Sep 2025 SUPPL
Label · Labeling
Dec 2022 SUPPL
Label · Labeling
Apr 2022 SUPPL
Label · Labeling

What TRIPTODUR KIT Treats

1 indications

TRIPTODUR KIT is approved for 1 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Prostate Cancer
Source: FDA Label

TRIPTODUR KIT 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.

What's emerging in TRIPTODUR KIT's indications

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Phase 3 candidates targeting molecules with no FDA-approved drug, in indications TRIPTODUR KIT treats. First-in-class if their pivotal trials read out positive.

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Clinical Trial Registry

4 trials
Trial Sponsor ID Phase Status Title
NCT06513962 ALTE2131 NCI-2024-05414, ALTE2131 Ph 3 recruiting Triptorelin for the Prevention of Ovarian Damage in Adolescents and Young Adults With Cancer
NCT05029622 results posted D-CN-52014-244 2022-003857-78 Ph 3 completed A Study to Assess the Efficacy and Safety of the Triptorelin 6-month Formulation in Paediatric Participants With Central Precocious Puberty.
NCT02168062 results posted 135513 NCI-2015-01058 Ph 2 terminated Supportive Therapy in Androgen Deprivation Clinic in Improving Health Outcomes and Managing Side Effects in Patients With Prostate Cancer
NCT01161563 results posted TRE1001 Ph 4 completed Randomized Crossover Trial to Assess the Tolerability of Gonadotropin Releasing Hormone (GnRH) Analogue Administration
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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.

TRIPTODUR KIT FDA Label Details

Indications & Usage

FDA Label (PDF)

TRIPTODUR KIT is indicated for the treatment of Prostate Cancer.

View full patent landscape →
1 OB patents · 1 families · 69 international docs across 33 countries

TRIPTODUR KIT Patents & Exclusivity

Latest Patent: Jun 2029

Patents (1 active)

US10166181 Expires Jun 30, 2029
Source: FDA Orange Book

Pro Intelligence Preview

Deep insights for TRIPTODUR KIT

Revenue Insights

  • Quarterly revenue tracking
  • Historical trend analysis

Patent Timeline

  • Cliff: 2029
  • 1 active patents

Trial Analysis

  • 4 total trials
  • Stage: Stable

Competitive Landscape

  • 20 similar drugs
  • Same target/indication analysis
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Data Sources

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