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Methadone · Dolophine Hydrochloride, Methadone Hydrochloride

Small molecule · Agonist of mu opioid receptor (OPRM1) · developed by Hikma Pharms

Approved FDA, Aug 1947
1 Registered trials

What is Methadone?

Methadone is a synthetic opioid that acts as a mu-opioid receptor agonist in the central nervous system and smooth-muscle organs, with some data indicating NMDA receptor antagonism. It is used in the management of severe pain and in the treatment of opioid addiction and dependence.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as
Dolophine Hydrochloride, Methadone Hydrochloride, Methadose
Drug type
Small molecule
Targets
mu opioid receptor (OPRM1), N-methyl-D-aspartate (NMDA) receptor (secondary target)
Mechanism
Agonist of mu opioid receptor (OPRM1)
Pathways
CNS opioid receptor signaling, NMDA receptor antagonism
Therapy area
Neurology, Oncology
Developer
Hikma Pharms
In trials of
AVIR
FDA status
Approved as Dolophine Hydrochloride, Methadone Hydrochloride, Methadose (August 13, 1947), NDA006134 · FDA label

✅ FDA-approved uses

From the indications section of the FDA label (version of Apr 27, 2026). Read the full label for the exact wording, limitations and safety information.

🧪 Clinical trials

TrialPhaseConditionStatusSponsor
NCT07314346 Phase 1 Healthy Volunteer Study Recruiting AVIR

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Healthy Volunteer Study

Other drugs acting on OPRM1

Morphine FDA approved Nalbuphine FDA approved Naloxone FDA approved Naltrexone FDA approved Oxycodone FDA approved PF614 Phase 3

Sources

Updated Oct 11, 2026.

Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z

This data is for informational purposes only, not investment advice. BioRadar does not provide buy/sell recommendations. Past performance does not guarantee future results. Always do your own due diligence.