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Norditropin® FlexPro®
Norditropin® FlexPro® is a Small molecule drug developed by Novo Nordisk A/S. It is currently in Phase 2 development.
Norditropin FlexPro is a recombinant human growth hormone injection used to treat various growth hormone deficiencies in children and adults, including growth hormone deficiency in children, born small for gestational age, and adult growth hormone deficiency. It works as a growth hormone receptor agonist, binding to the growth hormone receptor to stimulate growth.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% 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 | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Norditropin® FlexPro® |
|---|---|
| Sponsor | Novo Nordisk A/S |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- A Research Study to Compare Somapacitan Once a Week With Norditropin® Once a Day in Children Who Need Help to Grow (PHASE3)
- A Study of GenSci134 in Children With Growth Hormone Deficiency (PGHD) (PHASE1, PHASE2)
- A Study (Phase 1b/2) of GenSci134 in Children With Idiopathic Short Stature (ISS) (PHASE1, PHASE2)
- Investigating Efficacy and Safety of Once-weekly NNC0195-0092 Treatment Compared to Daily Growth Hormone Treatment (Norditropin® FlexPro®) in Growth Hormone Treatment naïve Pre-pubertal Children With Growth Hormone Deficiency (PHASE2)
- A Research Study in Chinese Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day. (PHASE3)
- A Research Study in Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day (REAL4) (PHASE3)
- Influence of Adherence to Growth Hormone Therapy (GHT) With Norditropin® on Near Final Height in Patients With Growth Hormone Deficiency (GHD) and Born Small for Gestational Age (SGA)
- Growth Hormone Replacement Therapy for Retried Professional Football Players (PHASE2)
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:
- Norditropin® FlexPro® CI brief — competitive landscape report
- Norditropin® FlexPro® updates RSS · CI watch RSS
- Novo Nordisk A/S portfolio CI
Frequently asked questions about Norditropin® FlexPro®
What is Norditropin® FlexPro®?
Who makes Norditropin® FlexPro®?
What development phase is Norditropin® FlexPro® in?
Related
- Manufacturer: Novo Nordisk A/S — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing