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Dosing 1: Atomoxetine
Dosing 1: Atomoxetine is a Small molecule drug developed by Apnimed. It is currently in Phase 1 development. Also known as: 40mg or 80 mg Atomoxetine.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Dosing 1: Atomoxetine |
|---|---|
| Also known as | 40mg or 80 mg Atomoxetine |
| Sponsor | Apnimed |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Evaluating the Efficacy of Atomoxetine in Reducing Primary Nocturnal Enuresis in Children With ADHD: A Randomized, Placebo-Controlled Study (EARLY_PHASE1)
- Study for Efficacy and Dose Escalation of AD313 + Atomoxetine (SEED) (PHASE1, PHASE2)
- Evaluation of Atomoxetine for Cocaine Dependence: A Pilot Trial (PHASE2)
- Effectiveness of ATMX in Treating Adolescents With ADHD and SUD (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:
- Dosing 1: Atomoxetine CI brief — competitive landscape report
- Dosing 1: Atomoxetine updates RSS · CI watch RSS
- Apnimed portfolio CI
Frequently asked questions about Dosing 1: Atomoxetine
What is Dosing 1: Atomoxetine?
Who makes Dosing 1: Atomoxetine?
Is Dosing 1: Atomoxetine also known as anything else?
What development phase is Dosing 1: Atomoxetine in?
Related
- Manufacturer: Apnimed — full pipeline
- Also known as: 40mg or 80 mg Atomoxetine
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing