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NNC0442-0344 A
NNC0442-0344 A is a Small molecule drug developed by Novo Nordisk A/S. It is currently in Phase 1 development. Also known as: Inno8.
NNC0442-0344 A is a treatment being studied in a clinical trial for Haemophilia A. The trial, NCT07238816, is a single-centre, open-label, randomized study sponsored by Novo Nordisk A/S.
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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). -
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 | 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 | NNC0442-0344 A |
|---|---|
| Also known as | Inno8 |
| Sponsor | Novo Nordisk A/S |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- A Research Study Looking at How Different Doses of Study Medicine (Inno8) Work in the Body of People With Haemophilia A (PHASE1)
- A Research Study Looking at How Food Intake Affects Inno8 in the Body of Healthy People (PHASE1)
- A Study Looking at How Different Doses of Study Medicine (Inno8) Works in the Body of Healthy Men (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:
- NNC0442-0344 A CI brief — competitive landscape report
- NNC0442-0344 A updates RSS · CI watch RSS
- Novo Nordisk A/S portfolio CI
Frequently asked questions about NNC0442-0344 A
What is NNC0442-0344 A?
Who makes NNC0442-0344 A?
Is NNC0442-0344 A also known as anything else?
What development phase is NNC0442-0344 A in?
Related
- Manufacturer: Novo Nordisk A/S — full pipeline
- Also known as: Inno8
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing