Drugs / Centanafadine
Centanafadine
also known as
EB-1020 · CTN · Centanafadina · CENTANAFADINE HYDROCHLORIDE · CTN SR · DOV 216,419 · DOV 216,419 free base · DOV 216,419 HYDROCHLORIDE · +2 more
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | SYMTRIYO | — | 2026-07-24 | fda.gov ↗ |
Trials 25 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT01744808 Comparator | Feb 2013 → Feb 2014 | — | Otsuka Pharmaceutical Development & Commercialization, Inc. | Completed | No outcome recorded |
Press releases naming this drug 14 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-07-27 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Receives FDA Approval for First-in-Class SIMTRIYO (centanafadine) for the Treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in Adults and Pediatric Patients Aged 6 Years and Older® otsuka.co.jp ↗ |
| 2026-07-24 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Receives FDA Approval for First-in-Class SIMTRIYO® (centanafadine) for the Treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in Adults and Pediatric Patients Aged 6 Years and Older otsuka-us.com ↗ |
| 2026-06-25 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Announces Positive Phase 3b Results for Centanafadine in Adults with ADHD and Comorbid Anxiety otsuka.co.jp ↗ |
| 2026-06-25 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Announces Positive Phase 3b Results for Centanafadine in Adults with ADHD and Comorbid Anxiety otsuka-us.com ↗ |
| 2026-05-29 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Presents New Phase 3 Post Hoc Analyses of Centanafadine Highlighting Improvement in Executive Function and Emotional Dysregulation in Adults with ADHD at the 2026 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting otsuka.co.jp ↗ |
| 2026-05-28 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Presents New Phase 3 Post Hoc Analyses of Centanafadine Highlighting Improvement in Executive Function and Emotional Dysregulation in Adults with ADHD at the 2026 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting otsuka-us.com ↗ |
| 2026-01-27 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Announces FDA Acceptance and Priority Review of New Drug Application for Centanafadine for the Treatment of ADHD in Children, Adolescents, and Adults otsuka.co.jp ↗ |
| 2026-01-27 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Announces FDA Acceptance and Priority Review of New Drug Application for Centanafadine for the Treatment of ADHD in Children, Adolescents, and Adults otsuka-us.com ↗ |
| 2025-11-25 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Pharmaceutical Submits New Drug Application to U.S. FDA for Centanafadine for the Treatment of ADHD in Children, Adolescents, and Adults otsuka.co.jp ↗ |
| 2025-11-25 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Pharmaceutical Submits New Drug Application to U.S. FDA for Centanafadine for the Treatment of ADHD in Children, Adolescents, and Adults otsuka-us.com ↗ |
| 2023-10-27 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Pharmaceutical Announces Positive Topline Results from Two Pivotal Phase 3 Trials of Centanafadine as a Treatment for Adolescents and Children with Attention-Deficit/Hyperactivity Disorder (ADHD) otsuka.co.jp ↗ |
| 2023-10-27 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Pharmaceutical Announces Positive Topline Results from Two Pivotal Phase 3 Trials of Centanafadine as a Treatment for Adolescents and Children with Attention-Deficit/Hyperactivity Disorder (ADHD) otsuka-us.com ↗ |
| 2020-06-12 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Announces Positive Top-line Results from Two Phase 3 Studies of Centanafadine for the Treatment of Attention-deficit Hyperactivity Disorder (ADHD) in Adult Patients otsuka.co.jp ↗ |
| 2020-06-10 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Announces Positive Top-line Results from Two Phase 3 Studies of Centanafadine for the Treatment of Attention-deficit Hyperactivity Disorder (ADHD) in Adult Patients otsuka-us.com ↗ |
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 27 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Centanafadine | “to-be-marketed (TBM) centanafadine (CTN) once daily (QD) extended release (XR)” NCT07253441 ↗22“received centanafadine (CTN) 100 mg, sustained release (SR) tablet” NCT01939353 ↗ “Centanafadine (CTN) (Formerly Called EB-1020)” NCT02827513 ↗ “EB-1020 (Centanafadine) low dose” NCT07087327 ↗ “EB-1020 (Centanafadine) 164.4 mg” NCT06931080 ↗ “EB-1020 (Centanafadine) low dose” NCT07086313 ↗ “EB-1020 (Centanafadine) 164.4 mg” NCT06926829 ↗ |
| Known as | Centanafadina | ChEMBL registry synonym — accepted as the source's own label CHEMBL3301621 ↗ |
| Known as | CENTANAFADINE HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL3301621 ↗ |
| Known as | CTN | “to-be-marketed (TBM) centanafadine (CTN) once daily (QD) extended release (XR)” NCT07253441 ↗1“Centanafadine (CTN) (Formerly Called EB-1020)” NCT02827513 ↗ |
| Known as | CTN SR | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02547428 ↗ |
| Known as | DOV 216,419 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3301621 ↗ |
| Known as | DOV 216,419 free base | ChEMBL registry synonym — accepted as the source's own label CHEMBL3301621 ↗ |
| Known as | DOV 216,419 HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL3301621 ↗ |
| Known as | EB-1020 | “Centanafadine (CTN) (Formerly Called EB-1020)” NCT02827513 ↗ |
| Known as | EB-1020 free base | ChEMBL registry synonym — accepted as the source's own label CHEMBL3301621 ↗ |
| Known as | EB-1020 HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL3301621 ↗ |
| Modality | Small molecule | — CHEMBL3301621 ↗ |
| Route | Oral | “multiple oral rising doses of a SR formulation of EB-1020” NCT01744808 ↗ |