Last reviewed · How we verify
Non-denosumab
Non-denosumab is a Small molecule drug developed by Capital Medical University. It is currently in Phase 1 development.
-
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).
| 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 | Non-denosumab |
|---|---|
| Sponsor | Capital Medical University |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
- Arthralgia
- Hot flush
- Back pain
- Fatigue
- Pain in extremity
- Hypertension
- Constipation
- Bone pain
- Scar pain
- Spinal pain
- Oedema peripheral
- Diarrhoea
Key clinical trials
- The Comparison of Ibandronate and Zoledronic Acid After Denosumab Discontinuation (PHASE4)
- Zunsemetinib in Combination With Capecitabine in Patients With Hormone Receptor-Positive and HER2-Negative Metastatic Breast Cancer With Bone Metastasis (PHASE1, PHASE2)
- Prevention of Symptomatic Skeletal Events With Denosumab Administered Every 4 Weeks Versus Every 12 Weeks (PHASE3)
- NT-NOA - Novel Treatment of Some Men With Non-Obstructive Azoospermia (PHASE1, PHASE2)
- RANKL Inhibition and Mammographic Breast Density (PHASE2)
- Zanzalintinib for Metastatic Clear Cell Renal Cell Carcinoma With Bone Metastases (PHASE2)
- A Study Evaluating the Efficacy of PD-1 Inhibitor Combined With Denosumab and Chemotherapy in Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer Patients With Driver Gene-Negative Status (PHASE2)
- PRevEnting FracturEs in REnal Disease - 1 (PHASE4)
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:
- Non-denosumab CI brief — competitive landscape report
- Non-denosumab updates RSS · CI watch RSS
- Capital Medical University portfolio CI
Frequently asked questions about Non-denosumab
What is Non-denosumab?
Who makes Non-denosumab?
What development phase is Non-denosumab in?
What are the side effects of Non-denosumab?
Related
- Manufacturer: Capital Medical University — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing