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antidepressant non-response
antidepressant non-response is a Small molecule drug developed by Samsung Medical Center. It is currently in Phase 1 development. Also known as: fluoxetine, paroxetine, sertraline, milnacipran, venlafaxine, nortriptyline, mirtazapine.
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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 | antidepressant non-response |
|---|---|
| Also known as | fluoxetine, paroxetine, sertraline, milnacipran, venlafaxine, nortriptyline, mirtazapine |
| Sponsor | Samsung Medical Center |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Phase 3 Study of Adjunctive Treatment With Seltorexant in Adult and Elderly Participants With Major Depressive Disorder and Insomnia Symptoms (PHASE3)
- RNA Editing as a Biomarker of Antidepressant Response in Unipolar and Bipolar Depression (EDIT-ANDRE) (PHASE4)
- Impact of Depression on Thermoregulation
- Sequenced Treatment Alternatives to Relieve Adolescent Depression (STAR-AD) (PHASE1, PHASE2)
- Treating Negative Affect in Low Back Pain Patients (PHASE2, PHASE3)
- Cerebral and Anti-inflammatory Response Through Exercise - Mechanisms In Depressive Disorders (NA)
- BDNF Gene Polymorphism and Antidepressants Treatment (PHASE4)
- Sequential Multiple Assignment Randomized Trial for Bipolar Depression (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:
- antidepressant non-response CI brief — competitive landscape report
- antidepressant non-response updates RSS · CI watch RSS
- Samsung Medical Center portfolio CI
Frequently asked questions about antidepressant non-response
What is antidepressant non-response?
Who makes antidepressant non-response?
Is antidepressant non-response also known as anything else?
What development phase is antidepressant non-response in?
Related
- Manufacturer: Samsung Medical Center — full pipeline
- Also known as: fluoxetine, paroxetine, sertraline, milnacipran, venlafaxine, nortriptyline, mirtazapine
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing