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DHA plus Vitamin D
DHA plus Vitamin D is a Nutritional supplement combination Small molecule drug developed by Bambino Gesù Hospital and Research Institute. It is currently in Phase 3 development for Nutritional supplementation in premature infants or infants at risk for developmental deficiencies, Support of bone mineralization and neurodevelopmental outcomes in pediatric populations.
DHA (docosahexaenoic acid) and Vitamin D work together to support bone mineralization, immune function, and neurological development.
DHA (docosahexaenoic acid) and Vitamin D work together to support bone mineralization, immune function, and neurological development. Used for Nutritional supplementation in premature infants or infants at risk for developmental deficiencies, Support of bone mineralization and neurodevelopmental outcomes in pediatric populations.
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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).
| 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 | DHA plus Vitamin D |
|---|---|
| Sponsor | Bambino Gesù Hospital and Research Institute |
| Drug class | Nutritional supplement combination |
| Modality | Small molecule |
| Therapeutic area | Pediatrics / Nutritional supplementation |
| Phase | Phase 3 |
Mechanism of action
DHA is an omega-3 polyunsaturated fatty acid that supports brain and retinal development, while Vitamin D enhances calcium absorption and bone metabolism. Together, this combination is designed to optimize skeletal development and neurodevelopmental outcomes in pediatric populations, particularly in premature or at-risk infants.
Approved indications
- Nutritional supplementation in premature infants or infants at risk for developmental deficiencies
- Support of bone mineralization and neurodevelopmental outcomes in pediatric populations
Common side effects
- Gastrointestinal upset
- Hypercalcemia (with excessive Vitamin D)
Key clinical trials
- A Study of a Dietary Supplement on Serum Biomarkers in Children (NA)
- Evaluation of the Effect of FertyBiotic Pregnancy in the Metabolic Profile in Pregnant Women (NA)
- Bioavailability of Vitamin D(25(OH)D) and Omega-3 Fatty Acid (DHA) Enhanced Chicken
- Effect of a Dairy Product for Pregnant and Lactating Women on the Composition of Human Milk (NA)
- Effect of a Protein-Creatine-Omega3-Vitamin D Supplement on Glycemic Variability in Mexican Patients With Type 2 Diabetes (NA)
- Dietary Counselling Plus Omega-3 Supplementation in the Treatment of Generalized Anxiety Disorder (PHASE2)
- Omega-3 Fatty Acids and Subconcussive Head Impacts (NA)
- Healthy Early Life Moments in Singapore (NA)
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:
- DHA plus Vitamin D CI brief — competitive landscape report
- DHA plus Vitamin D updates RSS · CI watch RSS
- Bambino Gesù Hospital and Research Institute portfolio CI
Frequently asked questions about DHA plus Vitamin D
What is DHA plus Vitamin D?
How does DHA plus Vitamin D work?
What is DHA plus Vitamin D used for?
Who makes DHA plus Vitamin D?
What drug class is DHA plus Vitamin D in?
What development phase is DHA plus Vitamin D in?
What are the side effects of DHA plus Vitamin D?
Related
- Drug class: All Nutritional supplement combination drugs
- Manufacturer: Bambino Gesù Hospital and Research Institute — full pipeline
- Therapeutic area: All drugs in Pediatrics / Nutritional supplementation
- Indication: Drugs for Nutritional supplementation in premature infants or infants at risk for developmental deficiencies
- Indication: Drugs for Support of bone mineralization and neurodevelopmental outcomes in pediatric populations
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing