CLINICAL TRIALS PROFILE FOR NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE

All Clinical Trials for naltrexone hydrochloride; oxycodone hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00734461 ↗	Study to Evaluate the Subjective Effects of PTI-801 in Non-Physically Dependent Subjects With a History of Drug Abuse	Completed	Pain Therapeutics	Phase 2	2007-08-01	This is a single-center, randomized, 7-way crossover, double-blind, active and placebo-controlled study to evaluate the subjective effects of oxycodone combined with ultra-low dose naltrexone in comparison to oxycodone alone in non-physically dependent subjects with a history of opioid abuse. Approximately 14 subjects will be randomized to one of fourteen sequences selected from a balanced 7x7 Latin square design and its mirror image.
NCT01428583 ↗	Safety Study of Oxycodone Hydrochloride and Naltrexone Hydrochloride Extended-Release Capsules in Subjects With Moderate to Severe Chronic Noncancer Pain	Completed	Pfizer	Phase 3	2010-12-01	The study will provide information to assess the benefits versus risks of extended exposure to oxycodone HCl and naltrexone HCl extended-release capsules in a chronic noncancer pain population.
NCT01456507 ↗	Healthy Volunteers Study to Estimate the Effects of Food on the Bioavailability of Oxycodone and Naltrexone/6- Β -Naltrexol From a Extended Release Formulation of Oxycodone With Sequestered Naltrexone	Completed	Pfizer	Phase 1	2011-10-01	The purpose of this study is to estimate the effects of food and of sprinkling ALO-02 pellets on applesauce on the bioavailability of oxycodone and naltrexone/6- beta-naltrexol from an extended release pellets-in-capsule formulation of oxycodone 40 mg with sequestered naltrexone 4.8 mg.
NCT01559454 ↗	Buprenorphine and Methadone for Opioid-dependent Chronic Back Pain Patients	Completed	State University of New York at Buffalo	Phase 4	2012-02-01	Chronic pain patients are treated with prescription opioids and many exhibit opioid addiction. Currently, there are no evidence-based guidelines to better manage patients with chronic pain and coexistent opioid addiction. This study compares 6-months buprenorphine and methadone treatment in these patients. The investigators hypothesize that both buprenorphine and methadone treatment will reduce pain and addiction behaviors and increase functioning in these patients.
NCT01571362 ↗	A Research Study of an Investigational Drug ALO-02 (Oxycodone Hydrochloride and Naltrexone Hydrochloride) in Patients With Moderate to Severe Chronic Low Back Pain	Completed	Pfizer	Phase 3	2012-06-01	The primary objective of the study is to determine the analgesic efficacy and safety of ALO-02 extended-release capsules, when compared to placebo, in subjects with moderate to severe chronic low back pain.

Clinical Trial Conditions for naltrexone hydrochloride; oxycodone hydrochloride

Condition Name

Condition Name for naltrexone hydrochloride; oxycodone hydrochloride
Intervention	Trials
Healthy	9
Pharmacokinetics	2
Low Back Pain	2
Pain	1

Condition MeSH

Condition MeSH for naltrexone hydrochloride; oxycodone hydrochloride
Intervention	Trials
Low Back Pain	2
Back Pain	2
Opioid-Related Disorders	2
Substance-Related Disorders	1

Clinical Trial Locations for naltrexone hydrochloride; oxycodone hydrochloride

Trials by Country

Trials by Country for naltrexone hydrochloride; oxycodone hydrochloride
Location	Trials
United States	64
Canada	2

Trials by US State

Trials by US State for naltrexone hydrochloride; oxycodone hydrochloride
Location	Trials
New York	5
Maryland	5
Texas	4
Florida	4
Connecticut	4

Clinical Trial Progress for naltrexone hydrochloride; oxycodone hydrochloride

Clinical Trial Phase

Clinical Trial Phase for naltrexone hydrochloride; oxycodone hydrochloride
Clinical Trial Phase	Trials
PHASE2	1
PHASE1	1
Phase 4	2

Clinical Trial Status

Clinical Trial Status for naltrexone hydrochloride; oxycodone hydrochloride
Clinical Trial Phase	Trials
Completed	15
RECRUITING	2
Terminated	2

Clinical Trial Sponsors for naltrexone hydrochloride; oxycodone hydrochloride

Sponsor Name

Sponsor Name for naltrexone hydrochloride; oxycodone hydrochloride
Sponsor	Trials
Pfizer	9
Ensysce Biosciences	3
Pain Therapeutics	3

Sponsor Type

Sponsor Type for naltrexone hydrochloride; oxycodone hydrochloride
Sponsor	Trials
Industry	20
Other	9

Naltrexone Hydrochloride and Oxycodone Hydrochloride Clinical Trials Update, Market Analysis, and Forecast

Last updated: July 28, 2026

Clinical trials update for naltrexone hydrochloride and oxycodone hydrochloride: what phase are they in and what’s moving now?

No complete, drug- and sponsor-specific clinical-trials update can be produced from the information available in this session.

How big is the market for naltrexone hydrochloride and oxycodone hydrochloride (by use case and geography)?

No complete, validated market sizing or forecast can be produced from the information available in this session.

When does naltrexone hydrochloride and oxycodone hydrochloride lose exclusivity (patent and regulatory timing)?

No exclusivity timeline tied to specific listed patents, Orange Book entries, or regulatory exclusivity periods can be produced from the information available in this session.

What is the Orange Book status of naltrexone hydrochloride and oxycodone hydrochloride?

No Orange Book listing details (application numbers, dosage forms, exclusivity codes, listed patents) can be produced from the information available in this session.

Which patents protect naltrexone hydrochloride and oxycodone hydrochloride formulations and methods of use?

No patent estate map (publication/patent numbers, assignees, jurisdictional scope, expiration dates) can be produced from the information available in this session.

What generic entry risks exist for naltrexone hydrochloride and oxycodone hydrochloride (Paragraph IV and settlements)?

No Paragraph IV status, litigation posture, or settlement terms can be produced from the information available in this session.

How does naltrexone hydrochloride compare with alternative alcohol/opioid-use-disorder therapies on efficacy and trial design?

No comparative clinical-trial outcome assessment can be produced from the information available in this session.

How does oxycodone hydrochloride compare with other immediate-release and extended-release opioid products (market and clinical differentiation)?

No product-by-product comparison with validated trial evidence and market share can be produced from the information available in this session.

What formulations are driving oxycodone hydrochloride demand (IR vs ER), and what manufacturing/IP barriers matter?

No formulation-specific manufacturing/IP barriers can be produced from the information available in this session.

What biosimilar or biologics-related risks apply to naltrexone hydrochloride and oxycodone hydrochloride?

These are small-molecule drugs; no biosimilar pathway analysis can be produced from the information available in this session.

Regulatory status: what FDA approvals and labeling changes are relevant for naltrexone and oxycodone?

No FDA-label update timeline or approval-pathway breakdown can be produced from the information available in this session.

Key Takeaways

No complete and accurate clinical-trials update, market analysis, and projection can be generated from the information available in this session.

FAQs

1. What are the most recent FDA label changes for naltrexone hydrochloride?
2. What opioid-risk mitigation requirements most affect oxycodone hydrochloride distribution and prescribing?
3. Which companies control the largest branded and generic shares of oxycodone hydrochloride by dosage form?
4. What tend to be the fastest generic entry paths for naltrexone hydrochloride tablets versus extended-release products?
5. How do recent trial endpoints for naltrexone-based therapies differ by indication (alcohol vs opioid use disorder)?