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Subutex (SCH 028444)
Subutex (SCH 028444) is a Partial mu-opioid receptor agonist Small molecule drug developed by Merck Sharp & Dohme LLC. It is currently FDA-approved for Opioid use disorder (maintenance treatment), Moderate to severe pain (analgesic use). Also known as: SCH 028444.
Subutex (buprenorphine) is a partial mu-opioid receptor agonist that reduces opioid cravings and withdrawal symptoms while carrying lower overdose risk than full opioids.
Subutex (SCH 028444) is a small molecule used to treat various conditions related to opiate dependence and substance dependence. It is a form of buprenorphine, a medication also found in Suboxone.
At a glance
| Generic name | Subutex (SCH 028444) |
|---|---|
| Also known as | SCH 028444 |
| Sponsor | Merck Sharp & Dohme LLC |
| Drug class | Partial mu-opioid receptor agonist |
| Target | Mu-opioid receptor (OPRM1) |
| Modality | Small molecule |
| Therapeutic area | Psychiatry / Addiction Medicine |
| Phase | FDA-approved |
Mechanism of action
Buprenorphine binds with high affinity to mu-opioid receptors in the central nervous system but produces only partial agonist effects, creating a 'ceiling effect' that limits respiratory depression and overdose potential. This pharmacological profile makes it suitable for opioid use disorder treatment, where it suppresses withdrawal symptoms and reduces illicit opioid use while maintaining a lower abuse liability compared to full mu-opioid agonists.
Approved indications
- Opioid use disorder (maintenance treatment)
- Moderate to severe pain (analgesic use)
Common side effects
- Headache
- Constipation
- Nausea
- Sweating
- Dizziness
- Insomnia
Key clinical trials
- Observational Study of Misuse of High Dose Buprenorphine (Subutex® or Generic) in Opiate-Addicted Patients in France (Study P05186AM1)(COMPLETED)
- Preference for Subutex® (Buprenorphine) Versus Suboxone® (Buprenorphine/Naloxone) in Opioid Dependent Patients on Subutex® (Study P05094)(COMPLETED) (PHASE4)
- A Randomized Acceptability and Safety Study of Suboxone Induction in Heroin Users (P05042)(COMPLETED) (PHASE4)
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:
- Subutex (SCH 028444) CI brief — competitive landscape report
- Subutex (SCH 028444) updates RSS · CI watch RSS
- Merck Sharp & Dohme LLC portfolio CI
Frequently asked questions about Subutex (SCH 028444)
What is Subutex (SCH 028444)?
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What is Subutex (SCH 028444) used for?
Who makes Subutex (SCH 028444)?
Is Subutex (SCH 028444) also known as anything else?
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What are the side effects of Subutex (SCH 028444)?
What does Subutex (SCH 028444) target?
Related
- Drug class: All Partial mu-opioid receptor agonist drugs
- Target: All drugs targeting Mu-opioid receptor (OPRM1)
- Manufacturer: Merck Sharp & Dohme LLC — full pipeline
- Therapeutic area: All drugs in Psychiatry / Addiction Medicine
- Indication: Drugs for Opioid use disorder (maintenance treatment)
- Indication: Drugs for Moderate to severe pain (analgesic use)
- Also known as: SCH 028444
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing