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Etidronate
Etidronate is a Small molecule drug developed by Organon and Co. It is currently in Phase 3 development for Heterotopic ossification, Humoral hypercalcemia of malignancy, Osteitis deformans. Also known as: DIDRONEL®, Etidronate disodium, Didronel.
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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 | Etidronate |
|---|---|
| Also known as | DIDRONEL®, Etidronate disodium, Didronel |
| Sponsor | Organon and Co |
| Target | Type IV secretion-like conjugative transfer relaxase protein TraI |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
- Heterotopic ossification
- Humoral hypercalcemia of malignancy
- Osteitis deformans
Common side effects
Key clinical trials
- Treatment of Ectopic Calcification in Fahr's Disease or Syndrome (PHASE2)
- Effect of Different Chelation Protocols on the Healing of Periapical Lesions in Teeth With Chronic Apical Periodontitis (NA)
- Evaluation of the Effects of Different Irrigation Solutions and Activation Methods on Postoperative Pain and Quality of Life in Root Canal Treatment (NA)
- Effect of Different Irrigation Protocols on Postoperative Endodontic Pain and Inflammation (NA)
- Antibacterial Effect of NaOCl With Etidronic Acid in Apical Periodontitis Treatment (NA)
- Effect of Different Irrigation Solutions on Postoperative Pain and Lesion Healing (PHASE4)
- Comparing Different Single and Combination Chelating Agents on Sealer Penetration and Dentin Erosion. (NA)
- The Prevention of Systemic Ectopic Mineralization in Pseudoxanthoma Elasticum (PHASE3)
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:
- Etidronate CI brief — competitive landscape report
- Etidronate updates RSS · CI watch RSS
- Organon and Co portfolio CI
Frequently asked questions about Etidronate
What is Etidronate?
What is Etidronate used for?
Who makes Etidronate?
Is Etidronate also known as anything else?
What development phase is Etidronate in?
What does Etidronate target?
Related
- Target: All drugs targeting Type IV secretion-like conjugative transfer relaxase protein TraI
- Manufacturer: Organon and Co — full pipeline
- Therapeutic area: All drugs in Other
- Indication: Drugs for Heterotopic ossification
- Indication: Drugs for Humoral hypercalcemia of malignancy
- Indication: Drugs for Osteitis deformans
- Also known as: DIDRONEL®, Etidronate disodium, Didronel
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing