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Placebo for MFNS
Placebo for MFNS is a Small molecule drug developed by Organon and Co. It is currently in Phase 3 development for Mild to moderate menopausal flushing.
This drug is a placebo, meaning it has no active therapeutic effect.
This drug is a placebo, meaning it has no active therapeutic effect. Used for Mild to moderate menopausal flushing.
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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).
| 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 | Placebo for MFNS |
|---|---|
| Sponsor | Organon and Co |
| Modality | Small molecule |
| Phase | Phase 3 |
Mechanism of action
As a placebo, it does not interact with any biological systems or molecular targets. It is used as a control in clinical trials to compare the efficacy of active treatments.
Approved indications
- Mild to moderate menopausal flushing
Common side effects
- No adverse events are expected with a placebo.
Key clinical trials
- A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps (PHASE3)
- A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps (PHASE3)
- A Proof-of-concept Study of Lunsekimig Compared With Placebo in Adults With Chronic Rhinosinusitis With Nasal Polyps (PHASE2)
- A Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of Itepekimab (Anti--IL-33 mAb) in Participants With Chronic Rhinosinusitis Without Nasal Polyps (PHASE2)
- A Study of the Efficacy and Safety of Brensocatib in Participants With Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP) (PHASE2)
- Dupilumab for Prevention of Recurrence of CRSwNP After ESS (PHASE4)
- Effectiveness and Safety of Once or Twice Daily Mometasone Nasal Spray Versus Amoxicillin Versus Placebo for Treatment of Acute Rhinosinusitis (Study P02683) (PHASE2)
- Mometasone Furoate Nasal Spray for Treatment of Nasal Polyposis After Surgery (Study P03218) (PHASE3)
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:
- Placebo for MFNS CI brief — competitive landscape report
- Placebo for MFNS updates RSS · CI watch RSS
- Organon and Co portfolio CI
Frequently asked questions about Placebo for MFNS
What is Placebo for MFNS?
How does Placebo for MFNS work?
What is Placebo for MFNS used for?
Who makes Placebo for MFNS?
What development phase is Placebo for MFNS in?
What are the side effects of Placebo for MFNS?
Related
- Manufacturer: Organon and Co — full pipeline
- Indication: Drugs for Mild to moderate menopausal flushing
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing