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RGB-14-P
RGB-14-P is a Serotonin receptor antagonist Small molecule drug developed by Gedeon Richter Plc.. It is currently in Phase 3 development for Treatment-resistant depression.
RGB-14-P is a small molecule that targets the serotonin receptor.
RGB-14-P is a small molecule inhibitor of cyclin-dependent kinase 1, classified as an inhibitor. It is being studied in a clinical trial (NCT05087030) for the treatment of postmenopausal osteoporosis, in comparison to Prolia.
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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 | RGB-14-P |
|---|---|
| Sponsor | Gedeon Richter Plc. |
| Drug class | Serotonin receptor antagonist |
| Target | 5-HT2A receptor |
| Modality | Small molecule |
| Therapeutic area | Psychiatry |
| Phase | Phase 3 |
Mechanism of action
It works by binding to the serotonin receptor, which helps to regulate various physiological processes. This interaction can lead to therapeutic effects in certain conditions.
Approved indications
- Treatment-resistant depression
Common side effects
- Dizziness
Key clinical trials
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:
- RGB-14-P CI brief — competitive landscape report
- RGB-14-P updates RSS · CI watch RSS
- Gedeon Richter Plc. portfolio CI
Frequently asked questions about RGB-14-P
What is RGB-14-P?
How does RGB-14-P work?
What is RGB-14-P used for?
Who makes RGB-14-P?
What drug class is RGB-14-P in?
What development phase is RGB-14-P in?
What are the side effects of RGB-14-P?
What does RGB-14-P target?
Related
- Drug class: All Serotonin receptor antagonist drugs
- Target: All drugs targeting 5-HT2A receptor
- Manufacturer: Gedeon Richter Plc. — full pipeline
- Therapeutic area: All drugs in Psychiatry
- Indication: Drugs for Treatment-resistant depression
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing