Product Description
Naltrexone is a prescription drug. It belongs to a group of drugs known as opioid antagonists. These block the effects of heroin and other opioid drugs (Sourced from: https://adf.org.au/drug-facts/naltrexone/)
Mechanisms of Action: OPR Antagonist
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral,Intramuscular
FDA Designation: None *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Bangladesh | Belgium | Brazil | Bulgaria | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Ireland | Italy | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Netherlands | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: Pain Unspecified | Substance Abuse Unspecified | Pain Unspecified | Substance Abuse Unspecified | Hypertension | Dyslipidemia | General Diabetes | Type 2 Diabetes | Overweight | Weight Loss
Known Adverse Events: Constipation | Headache | Dizziness | Insomnia | Diarrhea
Company: Orexigen
Company Location: LA JOLLA CA 92037
Company CEO:
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, China, Germany, Korea, New Zealand, United States
Active Clinical Trial Count: 13
Highest Development Phases
Phase 3: Alcoholism|Fibromyalgia
Phase 2: Migraine Disorders|Opioid-Related Disorders|Suicidality
Phase 1: Conduct Disorder|Healthy Volunteers|Pain Unspecified|Substance Abuse Unspecified
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| GM0020 | P2 |
Not yet recruiting |
Opioid-Related Disorders |
2027-03-15 |
|
| NiNsSIB | P2 |
Not yet recruiting |
Suicidality |
2027-02-28 |
|
| A-06 | P2 |
Not yet recruiting |
Migraine Disorders |
2026-07-01 |
|
| A-06 | P2 |
Not yet recruiting |
Migraine Disorders |
2026-07-01 |
|
| BIOPIN101 | P1 |
Enrolling by invitation |
Opioid-Related Disorders |
2025-08-17 |