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Bonefos
Bonefos is a Small molecule drug developed by Kuopio University Hospital. It is currently in Phase 1 development.
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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).
| 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 | Bonefos |
|---|---|
| Sponsor | Kuopio University Hospital |
| Modality | Small molecule |
| Therapeutic area | Bone |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Combination Therapy: Hyperbaric Oxygen and PENTOCLO for Treatment of Osteoradionecrosis of the Mandible (PHASE3)
- Effect of Different Irrigation Protocols on Postoperative Endodontic Pain and Inflammation (NA)
- The PENTO Protocol in Medication-related Osteonecrosis of the Jaw (PHASE2)
- Clinical Trial to Assess Efficacy, Tolerability of Rising Doses of Clodronate in Painful Knee Osteoarthritis Patients (PHASE2, PHASE3)
- Combined Drug Therapy in Lateral Fragility Fractures of the Femur
- S0307 Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer. (PHASE3)
- Combination Chemotherapy in Treating Pain in Hormone Refractory Metastatic Prostate Cancer (PHASE3)
- Osteoradionecrosis and PENTOCLO Protocol: Retrospective Study
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:
- Bonefos CI brief — competitive landscape report
- Bonefos updates RSS · CI watch RSS
- Kuopio University Hospital portfolio CI
Frequently asked questions about Bonefos
What is Bonefos?
Who makes Bonefos?
What development phase is Bonefos in?
Related
- Manufacturer: Kuopio University Hospital — full pipeline
- Therapeutic area: All drugs in Bone
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing