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ALKS 9072
ALKS 9072 is a mu opioid receptor agonist combined with an opioid antagonist designed to provide analgesia while reducing abuse potential.
ALKS 9072 is a mu opioid receptor agonist combined with an opioid antagonist designed to provide analgesia while reducing abuse potential. Used for Moderate to severe acute pain.
At a glance
| Generic name | ALKS 9072 |
|---|---|
| Sponsor | Alkermes, Inc. |
| Drug class | Abuse-deterrent opioid analgesic |
| Target | Mu opioid receptor (with opioid antagonist component) |
| Modality | Small molecule |
| Therapeutic area | Pain Management |
| Phase | Phase 3 |
Mechanism of action
ALKS 9072 combines a mu opioid agonist with an opioid antagonist in a fixed-dose formulation intended to maintain analgesic efficacy while deterring misuse through antagonist activity if the formulation is tampered with or taken in ways other than intended. This abuse-deterrent approach aims to address the opioid crisis while preserving therapeutic pain relief benefits.
Approved indications
- Moderate to severe acute pain
Common side effects
- Nausea
- Constipation
- Dizziness
- Drowsiness
Key clinical trials
- A Study to Evaluate the Efficacy and Safety of ALKS 9072 (Also Known as Aripiprazole Lauroxil, ALKS 9070, or ARISTADA) in Subjects With Schizophrenia (PHASE3)
- A Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070) (PHASE3)
- A Study of ALKS 9072 in Subjects With Chronic Stable Schizophrenia (PHASE1)
- An Open-Label Study of Aripiprazole Lauroxil in Subjects With Stable Schizophrenia (PHASE1)
- An Extension of a Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070) (PHASE3)
- A Study of Aripiprazole Lauroxil in Subjects With Schizophrenia or Schizoaffective Disorder (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:
- ALKS 9072 CI brief — competitive landscape report
- ALKS 9072 updates RSS · CI watch RSS
- Alkermes, Inc. portfolio CI