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Paracalcitol
Paracalcitol is a Small molecule drug developed by Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy. It is currently in Phase 3 development. Also known as: Active form of Vitamin D..
Paracalcitol is a medication used to treat conditions such as secondary hyperparathyroidism, renal insufficiency, and hypercalcemia, particularly in patients undergoing hemodialysis. It is administered intravenously and is often compared to Zemplar (paricalcitol) in clinical trials.
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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 | Paracalcitol |
|---|---|
| Also known as | Active form of Vitamin D. |
| Sponsor | Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- Paricalcitol and Endothelial Function in Chronic Kidney Disease Patients (the PENNY Study) (PHASE3)
- Efficacy and Safety of Paricalcitol on the Treatment of Secondary Hyperparathyroidism in Calcitriol Resistant Dialysis Subjects (PHASE4)
- Effectiveness and Safety of IV Zemplar in Patients on Hemodialysis and With Secondary Hyperparathyroidism Using iPTH/100 as Initial Dose (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:
- Paracalcitol CI brief — competitive landscape report
- Paracalcitol updates RSS · CI watch RSS
- Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy portfolio CI
Frequently asked questions about Paracalcitol
What is Paracalcitol?
Who makes Paracalcitol?
Is Paracalcitol also known as anything else?
What development phase is Paracalcitol in?
Related
- Manufacturer: Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Active form of Vitamin D.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing