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Genotonorm
Genotonorm is a Small molecule drug developed by Pfizer. It is currently in Phase 3 development.
Genotonorm is a growth hormone receptor agonist, classified as an agonist drug. It is used to treat conditions such as hormone deficiency, growth hormone deficiency, and idiopathic short stature.
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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
Pfizer 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 | Genotonorm |
|---|---|
| Sponsor | Pfizer |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- Peri-operative Dynamics of the Growth Hormone Axis in Subjects With Acromegaly
- ALXN2420 Versus Placebo in Combination With Somatostatin Analogs in Participants With Acromegaly (PHASE2)
- Phase 3 Study of LUM-201 in Children With Growth Hormone Deficiency (PHASE3)
- Tesamorelin for Reduction of Liver Fat in Adults With Fatty Liver Disease (Mock Study) (PHASE2)
- Effects of Recombinant Human Growth Hormone in Elderly Patients With Moderate to Severe Acute Brain Injury (GH-ABI-RCT) (PHASE4)
- Recombinant Human Growth Hormone (rHGH) for Knee Osteoarthritis (KORR) (PHASE1, PHASE2)
- Study of Growth Hormone Inhibition Using Pegvisomant in Severe Insulin Resistance (PHASE2)
- A Phase 2 Study of Vosoritide in Children With Idiopathic Short Stature (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:
- Genotonorm CI brief — competitive landscape report
- Genotonorm updates RSS · CI watch RSS
- Pfizer portfolio CI
Frequently asked questions about Genotonorm
What is Genotonorm?
Who makes Genotonorm?
What development phase is Genotonorm in?
Related
- Manufacturer: Pfizer — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing