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responders
responders is a Small molecule drug developed by Samsung Medical Center. It is currently in Phase 1 development. Also known as: fluoxetine_Prozac, paroxetine_Paxil, Seroxat, sertraline_Zoloft, milnacipran.
Researchers have studied the effects of various interventions, including Radiation Therapy, Asunaprevir, and Daclatasvir, in clinical trials for conditions such as HIV Seropositivity, Squamous Cell Carcinoma of the Oropharynx, and Hepatitis C Virus. These trials have been conducted by organizations such as Assistance Publique - Hôpitaux de Paris, with one specific study focusing on the interaction between HIV and platelets in patients under cART treatment.
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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 | responders |
|---|---|
| Also known as | fluoxetine_Prozac, paroxetine_Paxil, Seroxat, sertraline_Zoloft, milnacipran, venlafaxine_Effexor |
| Sponsor | Samsung Medical Center |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Molecular Profiling in Tissue Samples From Patients With Cancer Who Are Exceptional Responders to Treatment
- "A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder" (PHASE3)
- Identification of Responders to Platelet-Rich Plasma (PRP) Injections in Lateral Elbow Epicondylalgia
- NIOSH R21 WTC Asthma
- Management of Catatonic Features in Adolescents With Profound Autism (NA)
- Biomarkers of Reaction To HIIT Exercise (NA)
- Multi-Center Study of Panosyl-Isomaltooligosaccharides Adjunctive to PPI Therapy to Treat GERD (PHASE2)
- Iron and Immune Response to Vaccine (IRONMUM) (NA)
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:
- responders CI brief — competitive landscape report
- responders updates RSS · CI watch RSS
- Samsung Medical Center portfolio CI
Frequently asked questions about responders
What is responders?
Who makes responders?
Is responders also known as anything else?
What development phase is responders in?
Related
- Manufacturer: Samsung Medical Center — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: fluoxetine_Prozac, paroxetine_Paxil, Seroxat, sertraline_Zoloft, milnacipran, venlafaxine_Effexor
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing