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Vitamin D3 (Low dose)
Vitamin D3 (Low dose) is a Vitamin D analog Small molecule drug developed by Shiraz University of Medical Sciences. It is currently in Phase 3 development for Rickets, Osteomalacia, Osteoporosis, Hypocalcemia. Also known as: cholecalciferol.
Vitamin D3 is a fat-soluble vitamin that plays a crucial role in maintaining strong bones, immune function, and overall health.
Vitamin D3, a low-dose supplement, has been studied in various clinical trials for conditions such as obesity, vitamin D deficiency, chronic pain syndrome, inflammatory response, and healthy individuals. The exact mechanism of action of Vitamin D3 is unknown, but it has been used as an intervention in studies examining its effects on insulin resistance and cardiovascular risk factors in obese adolescents.
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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). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
| 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 | Vitamin D3 (Low dose) |
|---|---|
| Also known as | cholecalciferol |
| Sponsor | Shiraz University of Medical Sciences |
| Drug class | Vitamin D analog |
| Modality | Small molecule |
| Therapeutic area | Endocrinology, Nephrology, Rheumatology |
| Phase | Phase 3 |
Mechanism of action
It works by regulating calcium levels in the body, which is essential for bone growth and maintenance. Vitamin D3 also has immunomodulatory effects, helping to regulate the immune system's response to infections and autoimmune diseases.
Approved indications
- Rickets, Osteomalacia, Osteoporosis, Hypocalcemia
Common side effects
- Hypercalcemia
Key clinical trials
- Effect of Vitamin D and Folic Acid on Mild Cognitive Impairment (NA)
- Omega-3 Supplementation and Mental Health in College Students (NA)
- Assessment of Medrol Dosepak to Reduce Opioid Consumption in Foot and Ankle Surgical Patients (PHASE2)
- Setrusumab vs Placebo for Osteogenesis Imperfecta (PHASE2, PHASE3)
- Low vs. Moderate to High Dose Vitamin D for Prevention of COVID-19 (NA)
- The Investigation of Vitamin D and Menstrual Cycles Trial, the inVitD Trial: A Phase II Clinical Trial (PHASE2)
- Effects of Total Thyroid Removal on Parathyroid Function and Quality of Life (NA)
- Impact of Vitamin D Therapy on Thyroid Function and Antibody Levels in Pediatric Graves' Disease (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:
- Vitamin D3 (Low dose) CI brief — competitive landscape report
- Vitamin D3 (Low dose) updates RSS · CI watch RSS
- Shiraz University of Medical Sciences portfolio CI
Frequently asked questions about Vitamin D3 (Low dose)
What is Vitamin D3 (Low dose)?
How does Vitamin D3 (Low dose) work?
What is Vitamin D3 (Low dose) used for?
Who makes Vitamin D3 (Low dose)?
Is Vitamin D3 (Low dose) also known as anything else?
What drug class is Vitamin D3 (Low dose) in?
What development phase is Vitamin D3 (Low dose) in?
What are the side effects of Vitamin D3 (Low dose)?
Related
- Drug class: All Vitamin D analog drugs
- Manufacturer: Shiraz University of Medical Sciences — full pipeline
- Therapeutic area: All drugs in Endocrinology, Nephrology, Rheumatology
- Indication: Drugs for Rickets, Osteomalacia, Osteoporosis, Hypocalcemia
- Also known as: cholecalciferol
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing