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Vigantol
Vigantol is a Small molecule drug developed by Karolinska University Hospital. It is currently in Phase 1 development.
Vigantol, also known as cholecalciferol, is a small molecule that acts as a vitamin D3 receptor agonist. It has been studied in clinical trials for various conditions, including pulmonary tuberculosis, chronic heart failure, and multiple sclerosis.
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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 | Vigantol |
|---|---|
| Sponsor | Karolinska University Hospital |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- High-Dose Vitamin D Supplementation and Exercise Effects on Vitamin D Metabolites in Professional Football Players (NA)
- Vitamin Deficiency in Immigrants, a Treatment Study (PHASE4)
- The Effect of Supplementation of Vitamin D3 on Inflammation Induced by 100 km Running, Iron Metabolism and Erythropoiesis (NA)
- A Study to Examine the Effectiveness of Aspirin and/or Vitamin D3 to Prevent Prostate Cancer Progression (PHASE2, PHASE3)
- Vitamine D Treatment in Chronic Heart Failure (PHASE3)
- Vitamin-D Supplementation: Impact on Severe Pneumonia Among Under-five Children (PHASE1)
- Efficacy Study of Vitamin D Supplementation to Meticillin Resistant Staphylococcus Aureus (MRSA) Carriers (PHASE2)
- Dose-related Effects of Vitamin D3 on Immune Responses in Patients With Clinically Isolated Syndrome (PHASE1, PHASE2)
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:
- Vigantol CI brief — competitive landscape report
- Vigantol updates RSS · CI watch RSS
- Karolinska University Hospital portfolio CI
Frequently asked questions about Vigantol
What is Vigantol?
Who makes Vigantol?
What development phase is Vigantol in?
Related
- Manufacturer: Karolinska University Hospital — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing