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Neridronate
Neridronate is a Small molecule drug developed by Ente Ospedaliero Ospedali Galliera. It is currently in Phase 3 development for Humoral hypercalcemia of malignancy, Osteoporosis.
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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).
| 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 | Neridronate |
|---|---|
| Sponsor | Ente Ospedaliero Ospedali Galliera |
| Target | Farnesyl pyrophosphate synthase |
| Modality | Small molecule |
| Therapeutic area | Bone |
| Phase | Phase 3 |
Approved indications
- Humoral hypercalcemia of malignancy
- Osteoporosis
Common side effects
Key clinical trials
- Evaluation of IV AMBTX-01 (Neridronate) for Treatment of CRPS Type 1 (CRPS-RISE) (PHASE3)
- Efficacy and Safety of Intravenous Neridronic Acid in CRPS (PHASE3)
- Efficacy and Safety of Intravenous Neridronic Acid in Complex Regional Pain Syndrome (CRPS) (PHASE3)
- Efficacy and Safety of Neridronate (Nerixia®)to Treat Osteoporosis in Patients With TM and TI (PHASE2)
- Safety of Intravenous Neridronic Acid in CRPS (PHASE3)
- Efficacy and Safety of Intravenous Neridronic Acid in CRPS-I (PHASE2, PHASE3)
- Efficacy Study of Neridronate to Treat Painful Osteoarthritis of the Knee With Bone Marrow Lesions. (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:
- Neridronate CI brief — competitive landscape report
- Neridronate updates RSS · CI watch RSS
- Ente Ospedaliero Ospedali Galliera portfolio CI
Frequently asked questions about Neridronate
What is Neridronate?
What is Neridronate used for?
Who makes Neridronate?
What development phase is Neridronate in?
What does Neridronate target?
Related
- Target: All drugs targeting Farnesyl pyrophosphate synthase
- Manufacturer: Ente Ospedaliero Ospedali Galliera — full pipeline
- Therapeutic area: All drugs in Bone
- Indication: Drugs for Humoral hypercalcemia of malignancy
- Indication: Drugs for Osteoporosis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing