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Drug intelligence / Profile preview
SequestOx
- Development stage
- Phase 3
- Lead developer
- Elite Pharmaceuticals
- Modality
- Small Molecules
- Administration
- Oral
01
Overview
**SequestOx** is an investigational, immediate-release oral fixed-dose combination of oxycodone hydrochloride and sequestered naltrexone hydrochloride developed by Elite Pharmaceuticals for management of moderate to severe acute pain when an opioid analgesic is appropriate. Intact capsules are designed to release oxycodone for analgesia while retaining naltrexone within the formulation. If the capsule beads are crushed, chewed, or dissolved, naltrexone is released to antagonize opioid receptors and reduce the euphoric effects sought through tampering. Its NDA received an FDA Complete Response Letter in July 2016; Elite subsequently conducted reformulation and bioequivalence work, but reported in its fiscal-year 2026 filing that branded-product development was paused.
- Brand names
- SequestOx
- Other names
- oxycodone + naltrexoneoxycodone + sequestered naltrexoneoxycodone hydrochloride + naltrexone hydrochloride
02
Targets
DOR (Opioid Receptor Delta 1)KOR (Kappa opioid receptor)MOR (Mu opioid receptor)
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