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Single high dose vitamin D
Single high dose vitamin D is a Small molecule drug developed by Prof. Dr. Jörg Leuppi. It is currently in Phase 1 development. Also known as: VITAMIN D3 oil 500 IU/drop.
Vitamin D3 has been studied as a potential treatment for various conditions, including obesity, dyslipidemias, and osteogenesis imperfecta, according to ClinicalTrials.gov. The exact mechanism of action of vitamin D3 is currently unknown, as indicated by ChEMBL.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Single high dose vitamin D |
|---|---|
| Also known as | VITAMIN D3 oil 500 IU/drop |
| Sponsor | Prof. Dr. Jörg Leuppi |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Setrusumab vs Placebo for Osteogenesis Imperfecta (PHASE2, PHASE3)
- All-Trans Retinoic Acid (ATRA) Plus PD-1 Inhibition in Recurrent IDH-Mutant Glioma (PHASE2)
- Effects of Total Thyroid Removal on Parathyroid Function and Quality of Life (NA)
- High-Dose Vitamin D Supplementation and Exercise Effects on Vitamin D Metabolites in Professional Football Players (NA)
- Peripheral Immunological Effects of High-dose Vitamin D Treatment in Healthy Subjects (NA)
- Evaluation of the Role of N Acetyl Cysteine and Vitamin D in Improving Outcomes After Corrosive Ingestion (PHASE3)
- Pilot Study of OMEGA-3 and Vitamin D in High-Dose in Type I Diabetic Patients (PHASE1, PHASE2)
- Preoperative Correction of Vitamin D Deficiency in Total Joint Arthroplasty (TJA) (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:
- Single high dose vitamin D CI brief — competitive landscape report
- Single high dose vitamin D updates RSS · CI watch RSS
- Prof. Dr. Jörg Leuppi portfolio CI
Frequently asked questions about Single high dose vitamin D
What is Single high dose vitamin D?
Who makes Single high dose vitamin D?
Is Single high dose vitamin D also known as anything else?
What development phase is Single high dose vitamin D in?
Related
- Manufacturer: Prof. Dr. Jörg Leuppi — full pipeline
- Also known as: VITAMIN D3 oil 500 IU/drop
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing