Last reviewed · How we verify
ALO-02
ALO-02, marketed by Pfizer, is a small molecule therapy with a key composition patent expiring in 2028. The drug's mechanism of action involves interacting with a specific biological target to produce a therapeutic effect, positioning it as a targeted treatment option. The primary risk is the patent expiry in 2028, which could lead to increased competition from generics.
At a glance
| Generic name | ALO-02 |
|---|---|
| Also known as | oxycodone HCl and naltrexone HCl, oxycodone hydrochloride/naltrexone hydrochloride |
| Sponsor | Pfizer |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
Common side effects
Key clinical trials
- A Study to Characterize the Abuse Liability of ALO-02 in Healthy, Non-Dependent, Recreational Opioid Abusers (PHASE1)
- A Randomized, Two-way, Crossover Study to Estimate the Relative Bioavailability of a Controlled-release Formulation of Oxycodone (40 mg) With Sequestered Naltrexone Compared With Immediate-release Oxycodone Tablets (20 mg) in Healthy Volunteers
- 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 (PHASE1)
- Safety and Pharmacokinetic Study of ALO-02 in Children Ages 7-17 With Pain (PHASE4)
- A Study to Characterize the Abuse Liability of ALO-02 in Healthy, Non-Dependent, Recreational Opioid Users When ALO-02 Capsules Are Crushed and Snorted (PHASE1)
- A Research Study of an Investigational Drug ALO-02 (Oxycodone Hydrochloride and Naltrexone Hydrochloride) in Patients With Moderate to Severe Chronic Low Back Pain (PHASE3)
- Safety Study of Oxycodone Hydrochloride and Naltrexone Hydrochloride Extended-Release Capsules in Subjects With Moderate to Severe Chronic Noncancer Pain (PHASE3)
- Study to Determine the Effects of Co-Administration of Alcohol on the Absorption of Oxycodone From a Proprietary Controlled-Release Formulation (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- ALO-02 CI brief — competitive landscape report
- ALO-02 updates RSS · CI watch RSS
- Pfizer portfolio CI