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Reboxetine Pill
Reboxetine Pill is a Norepinephrine reuptake inhibitor (NRI) Small molecule drug developed by Vrije Universiteit Brussel. It is currently in Phase 3 development for Major depressive disorder, Attention deficit hyperactivity disorder (ADHD).
Reboxetine selectively inhibits the reuptake of norepinephrine at the presynaptic neuron, increasing norepinephrine availability in the central nervous system.
Reboxetine is a small molecule that inhibits the sodium-dependent noradrenaline transporter, specifically the norepinephrine transporter. It has been studied in various clinical trials for conditions such as decision making, sleep apnea, stress urinary incontinence, and fecal incontinence.
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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 | Reboxetine Pill |
|---|---|
| Sponsor | Vrije Universiteit Brussel |
| Drug class | Norepinephrine reuptake inhibitor (NRI) |
| Target | Norepinephrine transporter (NET) |
| Modality | Small molecule |
| Therapeutic area | Psychiatry / Neurology |
| Phase | Phase 3 |
Mechanism of action
As a selective norepinephrine reuptake inhibitor (NRI), reboxetine blocks the norepinephrine transporter, preventing the reabsorption of norepinephrine from the synaptic cleft. This increases norepinephrine concentration in key brain regions involved in mood regulation and attention. Unlike SSRIs, reboxetine has minimal effects on serotonin reuptake, making it a norepinephrine-selective antidepressant.
Approved indications
- Major depressive disorder
- Attention deficit hyperactivity disorder (ADHD)
Common side effects
- Dry mouth
- Insomnia
- Sweating
- Tachycardia
- Urinary retention
- Headache
Key clinical trials
- The Role of the Brain in Mental and Physical Fatigue (PHASE3)
- Efficacy of Reboxetine and Methylphenidate Treatment on Attentional, Sensory and Emotional Dysregulation in Adults With PTSD (PHASE2)
- Reboxetine for Sleep Apnoea After ENT Surgery (PHASE2)
- Studying the Role of Brain Molecules for Decision Making (NA)
- Effects of Single Dose Citalopram and Reboxetine on Urethral and Anal Closure Function on Healthy Female Subjects (PHASE1)
- The Role of Dopaminergic and Noradrenergic Neurotransmission in Value- and Salience-based Decision-Making (NA)
- Reboxetine and Citalopram as an Adjunct Treatment to Second Generation Antipsychotics in the Treatment of Negative Symptoms of Schizophrenia (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:
- Reboxetine Pill CI brief — competitive landscape report
- Reboxetine Pill updates RSS · CI watch RSS
- Vrije Universiteit Brussel portfolio CI
Frequently asked questions about Reboxetine Pill
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Related
- Drug class: All Norepinephrine reuptake inhibitor (NRI) drugs
- Target: All drugs targeting Norepinephrine transporter (NET)
- Manufacturer: Vrije Universiteit Brussel — full pipeline
- Therapeutic area: All drugs in Psychiatry / Neurology
- Indication: Drugs for Major depressive disorder
- Indication: Drugs for Attention deficit hyperactivity disorder (ADHD)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing