TheraRadar
Data updated: May 26, 2026

TROXYCA ER (naltrexone hydrochloride)

Trial Activity: Stable 3 active trials
CNS Approved 2016-08-19
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

Ensysce Biosciences conducting 3 trials (30%)
27 indications explored (Broad Platform)
→ obesity (2 trials)
→ smoking cessation (2 trials)
→ bariatric surgery patients (2 trials)
1
Indication
--
Phase 3 Trials
9
Years on Market

Details

Status
Discontinued
First Approved
2016-08-19
Patent Cliff
2027

Pro Metrics

Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
CAPSULE, EXTENDED RELEASE

Companies

Pfizer
Active Ingredient: NALTREXONE HYDROCHLORIDE , OXYCODONE HYDROCHLORIDE

TROXYCA ER Approval History

2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
24 FDA actions from 2016 to 2017
May 2017 SUPPL
Update · REMS
FDA Letter
Dec 2016 SUPPL
Label · Labeling
FDA Letter Label
Sep 2016 SUPPL
Update · REMS
FDA Letter

What TROXYCA ER Treats

1 FDA approvals

Originally approved for its first indication in 2016 .

  • Other (1)
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Clinical Trial Registry

10 trials
Trial Sponsor ID Phase Status Title
NCT07398404 2000041823 1K23DA064898-01 Ph 1, Ph 2 not yet recruiting A Multiple Health Behavior Change (MHBC) Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Patients
NCT07224087 2000041069 Ph 1 recruiting Development of a MHBC Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Patients
NCT03482479 LoDoNaVasc VCRC5564 Ph 2 completed Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis
NCT04791969 results posted 20-32912 R01DA053171 Ph 2 completed Intermittent Oral Naltrexone Enhanced With an Ecological Momentary Intervention for Methamphetamine-using MSM
NCT05073679 ONPED results posted STUDY00014382 150408 Ph 2, Ph 3 terminated Oral Naltrexone In Pediatric Eating Disorders
NCT02454712 SAD PF614-101 Ph 1 completed Study of PF614 Compared to OxyContin® in Healthy Volunteers (PF614-101)
NCT05043766 PF614-102 Ph 1 completed Evaluation of Oral PF614 Relative to OxyContin (PF614-102)
NCT05090280 MPAR-101 QSC203698 5UH3DA047682-04 Ph 1 completed Pharmacokinetics of Oxycodone and PF614 Co-Administered with Nafamostat (PF614-MPAR-101)
NCT05955313 VN21 Ph 2 recruiting Effectiveness of Low-dose Naltrexone in Patients With Different Types of Vulvodynia
NCT03879460 TEST CANADA 2018-044 Ph 1 completed The Evaluation of Safety and Tolerance of Commercially Available Naltrexone Administered Daily - Assessment for CBRN Operations
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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.

TROXYCA ER FDA Label Details

View full patent landscape →
1 OB patents · 1 families · 33 international docs across 13 countries

TROXYCA ER Patents & Exclusivity

Latest Patent: Dec 2027

Patents (1 active)

US7815934 Expires Dec 12, 2027
Source: FDA Orange Book

Pro Intelligence Preview

Deep insights for TROXYCA ER

Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2027
  • • 36 active patents

Trial Analysis

  • • 10 total trials
  • • Stage: Stable

Competitive Landscape

  • • Competitor tracking
  • • Same target/indication analysis
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Full approval history • All patents • Revenue trends • Competitor analysis

Data Sources

FDA Approval: NDA207621 → 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