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Etalpha
Etalpha is a Small molecule drug developed by Helse Stavanger HF. It is currently in Phase 2 development. Also known as: Alfakalsidol.
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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 | Etalpha |
|---|---|
| Also known as | Alfakalsidol |
| Sponsor | Helse Stavanger HF |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
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:
- Etalpha CI brief — competitive landscape report
- Etalpha updates RSS · CI watch RSS
- Helse Stavanger HF portfolio CI
Frequently asked questions about Etalpha
What is Etalpha?
Who makes Etalpha?
Is Etalpha also known as anything else?
What development phase is Etalpha in?
Related
- Manufacturer: Helse Stavanger HF — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Alfakalsidol
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing