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Centanafadine SR
Centanafadine SR is a Triple monoamine reuptake inhibitor Small molecule drug developed by Otsuka Pharmaceutical Development & Commercialization, Inc.. It is currently in Phase 3 development for Attention-deficit/hyperactivity disorder (ADHD). Also known as: EB-1020, centanafadine, centanafadine XR.
Centanafadine is a triple monoamine reuptake inhibitor that blocks the reuptake of serotonin, norepinephrine, and dopamine.
Centanafadine is a triple monoamine reuptake inhibitor that blocks the reuptake of serotonin, norepinephrine, and dopamine. Used for Attention-deficit/hyperactivity disorder (ADHD).
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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 | Centanafadine SR |
|---|---|
| Also known as | EB-1020, centanafadine, centanafadine XR |
| Sponsor | Otsuka Pharmaceutical Development & Commercialization, Inc. |
| Drug class | Triple monoamine reuptake inhibitor |
| Target | Serotonin transporter (SERT), norepinephrine transporter (NET), dopamine transporter (DAT) |
| Modality | Small molecule |
| Therapeutic area | Psychiatry / Neurology |
| Phase | Phase 3 |
Mechanism of action
By inhibiting the reuptake of all three monoamine neurotransmitters (serotonin, norepinephrine, and dopamine), centanafadine increases their synaptic concentrations. The sustained-release (SR) formulation provides prolonged therapeutic levels. This triple mechanism distinguishes it from selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs).
Approved indications
- Attention-deficit/hyperactivity disorder (ADHD)
Common side effects
- Insomnia
- Headache
- Nausea
- Increased heart rate
- Dry mouth
Key clinical trials
- A Trial to Compare the Amount of Centanafadine That Enters the Bloodstream for Two Different Formulations of Centanafadine (PHASE1)
- A Trial to Characterize Differences in Blood Levels of Different Lots of Centanafadine QD XR and to Understand the Effect of Food on Blood Levels (PHASE1)
- A Trial of Centanafadine Efficacy, Safety, and Tolerability in Adult Subjects With Binge Eating Disorder (PHASE2)
- Efficacy of Centanafadine SR as a Potential Smoking Cessation Treatment (PHASE2)
- A Trial Evaluating the Long-term Safety and Tolerability of Centanafadine Sustained-release Tablets in Adults With Attention-Deficit/Hyperactivity Disorder (PHASE3)
- A Trial Evaluating the Efficacy, Safety, & Tolerability of Centanafadine Sustained-release Tablets in Adults With Attention-deficit/Hyperactivity Disorder (PHASE3)
- A Phase 1 Study to Investigate the Safety, Tolerance, Food Effect, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of Extended Release Formulations of Centanafadine (CTN) in Young Healthy Subjects (PHASE1)
- Safety and Efficacy Study of Centanafadine Sustained-Release (CTN SR) in Adults With Attention-Deficit Hyperactivity Disorder (ADHD) (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:
- Centanafadine SR CI brief — competitive landscape report
- Centanafadine SR updates RSS · CI watch RSS
- Otsuka Pharmaceutical Development & Commercialization, Inc. portfolio CI
Frequently asked questions about Centanafadine SR
What is Centanafadine SR?
How does Centanafadine SR work?
What is Centanafadine SR used for?
Who makes Centanafadine SR?
Is Centanafadine SR also known as anything else?
What drug class is Centanafadine SR in?
What development phase is Centanafadine SR in?
What are the side effects of Centanafadine SR?
What does Centanafadine SR target?
Related
- Drug class: All Triple monoamine reuptake inhibitor drugs
- Target: All drugs targeting Serotonin transporter (SERT), norepinephrine transporter (NET), dopamine transporter (DAT)
- Manufacturer: Otsuka Pharmaceutical Development & Commercialization, Inc. — full pipeline
- Therapeutic area: All drugs in Psychiatry / Neurology
- Indication: Drugs for Attention-deficit/hyperactivity disorder (ADHD)
- Also known as: EB-1020, centanafadine, centanafadine XR
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing