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Alphacalcidol
Alphacalcidol is a Small molecule drug developed by University of Ioannina. It is currently in Phase 2 development for Hyperparathyroidism, Hypoparathyroidism, Neonatal hypocalcemia.
Alfacalcidol is a small molecule that acts as a vitamin D receptor agonist, specifically targeting the vitamin D3 receptor. It is used for supplementation in humans and has been studied in clinical trials for various conditions, including osteoporosis, rheumatoid arthritis, and sarcopenia.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Alphacalcidol |
|---|---|
| Sponsor | University of Ioannina |
| Target | Sodium-dependent noradrenaline transporter, Vitamin D3 receptor |
| Modality | Small molecule |
| Therapeutic area | Nephrology |
| Phase | Phase 2 |
Approved indications
- Hyperparathyroidism
- Hypoparathyroidism
- Neonatal hypocalcemia
- Renal osteodystrophy
Common side effects
Key clinical trials
- Assessment of the Locally Administrated Vitamin D3 and Corticision Efficacy on Orthodontic Canine Retraction (NA)
- Effects of Total Thyroid Removal on Parathyroid Function and Quality of Life (NA)
- Pentoxifylline on Inflammatory Markers in Non-Diabetic Chronic Kidney Disease Patients (NA)
- Efficacy and Safety of Encaleret Compared to Standard of Care in Participants With ADH1 (PHASE3)
- Active Vitamin D And Reduced Dose Prednisolone for Treatment in Minimal Change Nephropathy (PHASE4)
- The Role of VitD in Rehabilitation of Idiopathic Adolescent Scoliosis (PHASE2)
- Vitamin D in Dialysis Patients - Diagnostic and Therapeutic Management
- A Study on the Prevention and Treatment of GIOP With Eldecalcitol (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:
- Alphacalcidol CI brief — competitive landscape report
- Alphacalcidol updates RSS · CI watch RSS
- University of Ioannina portfolio CI
Frequently asked questions about Alphacalcidol
What is Alphacalcidol?
What is Alphacalcidol used for?
Who makes Alphacalcidol?
What development phase is Alphacalcidol in?
What does Alphacalcidol target?
Related
- Target: All drugs targeting Sodium-dependent noradrenaline transporter, Vitamin D3 receptor
- Manufacturer: University of Ioannina — full pipeline
- Therapeutic area: All drugs in Nephrology
- Indication: Drugs for Hyperparathyroidism
- Indication: Drugs for Hypoparathyroidism
- Indication: Drugs for Neonatal hypocalcemia
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing