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Vitamin D alone
Vitamin D alone is a Vitamin/Steroid hormone Small molecule drug developed by Brigham and Women's Hospital. It is currently in Phase 3 development for Vitamin D deficiency prevention and treatment, COVID-19 prevention or severity reduction (phase 3 trial context).
Vitamin D acts as a steroid hormone that binds to the vitamin D receptor to regulate calcium and phosphate homeostasis, immune function, and cellular differentiation.
Vitamin D is a small molecule that acts as an agonist to the Vitamin D3 receptor. It functions as a Vitamin D receptor agonist, modulating its activity.
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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 D alone |
|---|---|
| Sponsor | Brigham and Women's Hospital |
| Drug class | Vitamin/Steroid hormone |
| Target | Vitamin D receptor (VDR) |
| Modality | Small molecule |
| Therapeutic area | Immunology/Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
Vitamin D is converted to its active form (calcitriol) in the kidneys and binds to the vitamin D receptor (VDR) in target tissues. This activates gene transcription involved in calcium absorption in the intestines, bone mineralization, immune cell regulation, and cell proliferation control. Vitamin D deficiency is associated with impaired immune function, increased infection risk, and various chronic diseases.
Approved indications
- Vitamin D deficiency prevention and treatment
- COVID-19 prevention or severity reduction (phase 3 trial context)
Common side effects
- Hypercalcemia
- Hypercalciuria
- Nausea
- Kidney stone formation
Key clinical trials
- Effects of Cofrogliptin on Beta-Cell Function in LADA Patients (NA)
- Effect of Local Use of Vitamin D on the Rate of Canine Distillization: a Split Mouth Randomized Control Trial (PHASE1)
- Protein Supplement and Exercise Training for the Treatment of Sarcopenia Risk in Older Adults (NA)
- Child Health, Agriculture and Integrated Nutrition (NA)
- Characterising Sleep Disorders in Children With Tourette Syndrome
- Genetic Alterations From Physical Therapy in Low Back Pain and Disc Degeneration (NA)
- PentoxIfylline and Tocopherol for the Treatment of Post-radiotherapy Fibrosis in Head and Neck Cancer Patients (PHASE1)
- A Trial of Etelcalcetide in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis (PHASE3)
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 D alone CI brief — competitive landscape report
- Vitamin D alone updates RSS · CI watch RSS
- Brigham and Women's Hospital portfolio CI
Frequently asked questions about Vitamin D alone
What is Vitamin D alone?
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Related
- Drug class: All Vitamin/Steroid hormone drugs
- Target: All drugs targeting Vitamin D receptor (VDR)
- Manufacturer: Brigham and Women's Hospital — full pipeline
- Therapeutic area: All drugs in Immunology/Infectious Disease
- Indication: Drugs for Vitamin D deficiency prevention and treatment
- Indication: Drugs for COVID-19 prevention or severity reduction (phase 3 trial context)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing