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Opramidol (OPIPRAMOL)
Opramidol (generic name: OPIPRAMOL) is a opipramol drug. It is currently in Phase 3 development for Depressive disorder.
Opipramol works by binding to the sigma non-opioid intracellular receptor 1, which helps to regulate mood and emotional responses.
Opramidol, also known as Opipramol, is a small molecule drug that targets the sigma non-opioid intracellular receptor 1. It belongs to the opipramol class and is used to treat depressive disorder. The commercial status of Opipramol is unclear, but it is not FDA-approved. As a result, its availability and safety profile may vary. Further research is needed to fully understand its pharmacological properties.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
CNS / neurology attrition
-3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | OPIPRAMOL |
|---|---|
| Drug class | opipramol |
| Target | Sigma non-opioid intracellular receptor 1 |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | Phase 3 |
Mechanism of action
Imagine your brain has a complex system of messengers that help you feel happy or sad. Opipramol helps to calm down the messengers that make you feel sad, which can help to improve your mood and reduce symptoms of depression.
Approved indications
- Depressive disorder
Common side effects
- General physical health deterioration
- Abnormal palmar/plantar creases
- Product prescribing error
- Dysmorphism
- Product monitoring error
- Hypoparathyroidism secondary
- Foetal exposure during pregnancy
- VACTERL syndrome
- CADASIL
- Fall
- Hemivertebra
- Transposition of the great vessels
Key clinical trials
- Selected Disorders and Sleep Bruxism
- Pharmacovigilance in Gerontopsychiatric Patients (PHASE3)
- Double Blind Placebo Control Opipramol-Baclofen Treatment for Addiction (EARLY_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:
- Opramidol CI brief — competitive landscape report
- Opramidol updates RSS · CI watch RSS
Frequently asked questions about Opramidol
What is Opramidol?
How does Opramidol work?
What is Opramidol used for?
What is the generic name of Opramidol?
What drug class is Opramidol in?
What development phase is Opramidol in?
What are the side effects of Opramidol?
What does Opramidol target?
Related
- Drug class: All opipramol drugs
- Target: All drugs targeting Sigma non-opioid intracellular receptor 1
- Therapeutic area: All drugs in Neuroscience
- Indication: Drugs for Depressive disorder
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing