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Multivitamins - vitamins B complex, C and E
Multivitamins - vitamins B complex, C and E is a Vitamin supplement / Multivitamin Small molecule drug developed by Harvard School of Public Health (HSPH). It is currently in Phase 3 development for Nutritional supplementation and disease prevention in general population, Potential reduction of cardiovascular disease risk.
B complex, C, and E vitamins act as essential cofactors and antioxidants to support cellular metabolism, energy production, and protection against oxidative stress.
Multivitamins containing vitamins B complex, C, and E have been studied in clinical trials for conditions such as pregnancy, premature birth, and micronutrient deficiencies. These trials have investigated the effects of multivitamins on pregnancy outcomes, but the results are not conclusive, as indicated by the completed status of the trial "A Trial of Micronutrients and Adverse Pregnancy Outcomes" (NCT00197548).
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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 | Multivitamins - vitamins B complex, C and E |
|---|---|
| Sponsor | Harvard School of Public Health (HSPH) |
| Drug class | Vitamin supplement / Multivitamin |
| Modality | Small molecule |
| Therapeutic area | Preventive Medicine / Nutritional Supplementation |
| Phase | Phase 3 |
Mechanism of action
B vitamins (B1, B2, B3, B5, B6, B12, folate) function as coenzymes in energy metabolism and nucleic acid synthesis. Vitamin C serves as a reducing agent and cofactor for collagen synthesis and immune function. Vitamin E acts as a lipophilic antioxidant protecting cell membranes from oxidative damage. Together, these vitamins support general health maintenance and may reduce risk of chronic disease.
Approved indications
- Nutritional supplementation and disease prevention in general population
- Potential reduction of cardiovascular disease risk
Common side effects
- Gastrointestinal upset (nausea, diarrhea)
- Headache
- Flushing (from niacin)
Key clinical trials
- This Randomized Trial Aims to Investigate the Efficacy of Balanced Nutritional Tablets-Comprehensive Multivitamin and Mineral Supplements- in Preventing Micronutrient Deficiencies Among Patients Utilizing GLP-1 RAs for Weight Loss in Comparison to a Placebo Control (PHASE4)
- An Investigator-initiated Trial to Assess the Effectiveness of Three Different Gummies (Curcumin Gummies, Vitamin C Gummies, and Vitamin B Complex Gummies) in Healthy Children (NA)
- Meta-analysis of Randomized Controlled Trials on Vitamins and Mineral Supplementation for CVD Prevention and Treatment
- A Trial of Micronutrients and Adverse Pregnancy Outcomes (PHASE3)
- Trial of Vitamins Among Children of HIV-infected Women (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:
- Multivitamins - vitamins B complex, C and E CI brief — competitive landscape report
- Multivitamins - vitamins B complex, C and E updates RSS · CI watch RSS
- Harvard School of Public Health (HSPH) portfolio CI
Frequently asked questions about Multivitamins - vitamins B complex, C and E
What is Multivitamins - vitamins B complex, C and E?
How does Multivitamins - vitamins B complex, C and E work?
What is Multivitamins - vitamins B complex, C and E used for?
Who makes Multivitamins - vitamins B complex, C and E?
What drug class is Multivitamins - vitamins B complex, C and E in?
What development phase is Multivitamins - vitamins B complex, C and E in?
What are the side effects of Multivitamins - vitamins B complex, C and E?
Related
- Drug class: All Vitamin supplement / Multivitamin drugs
- Manufacturer: Harvard School of Public Health (HSPH) — full pipeline
- Therapeutic area: All drugs in Preventive Medicine / Nutritional Supplementation
- Indication: Drugs for Nutritional supplementation and disease prevention in general population
- Indication: Drugs for Potential reduction of cardiovascular disease risk
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing