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naloxone IM
naloxone IM is a Small molecule drug developed by STAT Therapeutics Inc. It is currently in Phase 1 development.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | naloxone IM |
|---|---|
| Sponsor | STAT Therapeutics Inc |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
- Pruritus
- Dizziness
- Nasal pruritus
- Nausea
- Feeling hot
- Hyperhidrosis
- Hot flush
- Somnolence
- Tension headache
- Palpitations
- Tinnitus
- Ear discomfort
Key clinical trials
- Rapid Antidepressant Improvement Secondary to Excitatory Brain Responses (PHASE4)
- iSTEP-N 101b: Pharmacokinetics and Safety Study of Low- and High-Dose Naltrexone Implants vs Monthly Vivitrol in Healthy Volunteers (PHASE1)
- Safety and PK Study of BICX104 With or Without Bupropion Compared to Vivitrol (PHASE1)
- Proof of Concept (PoC) Evaluation of Naloxone Unique Intramuscular (IM) Injection (PHASE1)
- Pharmacodynamic Evaluation of Intramuscular Nalmefene Autoinjector 1.5 mg Compared to Intranasal Narcan 4 mg (PHASE1)
- Long-acting Buprenorphine vs. Naltrexone Opioid Treatments in CJS-involved Adults (PHASE4)
- Naltrexone for Overdose Prevention (PHASE2, PHASE3)
- The Effect of Chronic Pain on Delay Discounting in Methadone Patients (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:
- naloxone IM CI brief — competitive landscape report
- naloxone IM updates RSS · CI watch RSS
- STAT Therapeutics Inc portfolio CI
Frequently asked questions about naloxone IM
What is naloxone IM?
Who makes naloxone IM?
What development phase is naloxone IM in?
What are the side effects of naloxone IM?
Related
- Manufacturer: STAT Therapeutics Inc — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing