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Elontril
Elontril is a Small molecule drug developed by Boehringer Ingelheim. It is currently in Phase 3 development for Depressive disorder, Major depressive disorder, Nicotine dependence. Also known as: Bupropion hydrochloride.
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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). -
Big-pharma sponsor
+3.0pp
Boehringer Ingelheim is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| 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 | Elontril |
|---|---|
| Also known as | Bupropion hydrochloride |
| Sponsor | Boehringer Ingelheim |
| Target | Cytochrome P450 2C19, Neuronal acetylcholine receptor subunit alpha-7, Alpha-1A adrenergic receptor |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | Phase 3 |
Approved indications
- Depressive disorder
- Major depressive disorder
- Nicotine dependence
- Obesity
- Seasonal affective disorder
- Smoking cessation assistance
Common side effects
Key clinical trials
- A Study in Healthy Men and Women to Test Whether BI 1358894 Influences the Amount of Bupropion in the Blood (PHASE1)
- Single Dose Crossover Comparative Bioavailability Study of Bupropion Hcl MR Tablet 300mg (PHASE1)
- Study of Exposure to Substances Prohibited by the World Anti-Doping Agency in Healthy Volunteers. (PHASE1)
- Bupropion for the Treatment of Apathy in Alzheimer's Dementia (PHASE3)
- Apathy Cure Through Bupropion in Huntington's Disease (PHASE2)
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:
- Elontril CI brief — competitive landscape report
- Elontril updates RSS · CI watch RSS
- Boehringer Ingelheim portfolio CI
Frequently asked questions about Elontril
What is Elontril?
What is Elontril used for?
Who makes Elontril?
Is Elontril also known as anything else?
What development phase is Elontril in?
What does Elontril target?
Related
- Target: All drugs targeting Cytochrome P450 2C19, Neuronal acetylcholine receptor subunit alpha-7, Alpha-1A adrenergic receptor
- Manufacturer: Boehringer Ingelheim — full pipeline
- Therapeutic area: All drugs in Metabolic
- Indication: Drugs for Depressive disorder
- Indication: Drugs for Major depressive disorder
- Indication: Drugs for Nicotine dependence
- Also known as: Bupropion hydrochloride
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing