Last reviewed · How we verify
Dixeran (MELITRACEN)
Dixeran (generic name: MELITRACEN) is a Tricyclic Antidepressants drug. It is currently in Phase 3 development.
Dixeran works by inhibiting the reuptake of certain neurotransmitters, such as serotonin and norepinephrine, in the brain.
Dixeran, also known as MELITRACEN, is a small molecule Tricyclic Antidepressant. Its original developer and current owner are unknown. It is used to treat various conditions, but its exact target and approved indications are not specified. The commercial status of Dixeran is unclear, and it is not known whether it is patented or available as a generic medication. Further information on its pharmacokinetics and safety profile is also lacking.
-
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 | MELITRACEN |
|---|---|
| Drug class | Tricyclic Antidepressants |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | Phase 3 |
Mechanism of action
Imagine your brain is a city with many messengers running around, delivering important messages. Dixeran helps keep these messengers, called neurotransmitters, in the city longer, so they can do their job more effectively. This can help improve mood and reduce symptoms of depression.
Approved indications
Common side effects
Key clinical trials
- Efficacy of Gut-Brain Neuromodulators in the Treatment of Gastroesophageal Reflux Disease (NA)
- Assessment of SSD in Outpatients Using SSS-CN
- Effects of Cognitive Behavioral Therapy Through a Mobile App on Patients With Refractory Functional Dyspepsia (NA)
- Efficacy of Gut-Brain Neuromodulators for Functional Dyspepsia (NA)
- A Study on the Combined Use of Tocilizumab and Flupentixol-Melitracen in the Treatment of Thyroid-Associated Ophthalmopathy (PHASE4)
- Bioequivalence Study to Compare Two Formulations of Deanxit® (PHASE1)
- The Role of Neuromodulators in Refractory Functional Dyspepsia (NA)
- Flupentixol and Melitracen Tablets in the Treatment of Emotional Disorder (PHASE4)
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:
- Dixeran CI brief — competitive landscape report
- Dixeran updates RSS · CI watch RSS
Frequently asked questions about Dixeran
What is Dixeran?
How does Dixeran work?
What is the generic name of Dixeran?
What drug class is Dixeran in?
What development phase is Dixeran in?
Related
- Drug class: All Tricyclic Antidepressants drugs
- Therapeutic area: All drugs in Neuroscience
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing