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Placebo (Mim8)
Placebo (Mim8) is a Small molecule drug developed by Novo Nordisk A/S. It is currently in Phase 3 development.
Placebo (Mim8) is an inert control substance used in clinical trials to establish baseline efficacy and safety comparisons.
Mim8, also known as NNC0365-3769, is a Factor VIIIa-mimetic antibody being studied in clinical trials for conditions such as Haemophilia A. It is administered in various concentrations, including 10 mg/mL and 100 mg/mL, and is compared to a placebo in these trials.
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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). -
Big-pharma sponsor
+3.0pp
Novo Nordisk A/S is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| 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 (Mim8) |
|---|---|
| Sponsor | Novo Nordisk A/S |
| Modality | Small molecule |
| Phase | Phase 3 |
Mechanism of action
As a placebo, Mim8 contains no active pharmaceutical ingredient and serves as a comparator arm in phase 3 clinical trials. It allows researchers to distinguish genuine drug effects from placebo response and natural disease progression. The specific formulation and indication for this Novo Nordisk placebo are not publicly disclosed in standard pharmaceutical databases.
Approved indications
Common side effects
Key clinical trials
- A Research Study Investigating Mim8 in People With Haemophilia A (PHASE2)
- A Research Study of How a New Medicine NNC0365-3769 (Mim8) Works in the Body of Healthy People (PHASE1)
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 (Mim8) CI brief — competitive landscape report
- Placebo (Mim8) updates RSS · CI watch RSS
- Novo Nordisk A/S portfolio CI
Frequently asked questions about Placebo (Mim8)
What is Placebo (Mim8)?
How does Placebo (Mim8) work?
Who makes Placebo (Mim8)?
What development phase is Placebo (Mim8) in?
Related
- Manufacturer: Novo Nordisk A/S — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing