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Multivitamins - vitamins B complex, C and E

Harvard School of Public Health (HSPH) · Phase 3 active Small molecule Under review

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).

Likelihood of approval
58.3% vs 58.3% industry baseline
If approved by FDA: likely 2028–2030
Steps remaining: NDA/BLA submission
Confidence: High
Why this estimate
  • 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).
Predicted approval windows by jurisdiction (conditional on FDA approval)
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 nameMultivitamins - vitamins B complex, C and E
SponsorHarvard School of Public Health (HSPH)
Drug classVitamin supplement / Multivitamin
ModalitySmall molecule
Therapeutic areaPreventive Medicine / Nutritional Supplementation
PhasePhase 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

Common side effects

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
ClinicalTrials.govTrial enrolment, design, endpoints, results

Competitive intelligence

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Frequently asked questions about Multivitamins - vitamins B complex, C and E

What is Multivitamins - vitamins B complex, C and E?

Multivitamins - vitamins B complex, C and E is a Vitamin supplement / Multivitamin drug developed by Harvard School of Public Health (HSPH), indicated for Nutritional supplementation and disease prevention in general population, Potential reduction of cardiovascular disease risk.

How does Multivitamins - vitamins B complex, C and E work?

B complex, C, and E vitamins act as essential cofactors and antioxidants to support cellular metabolism, energy production, and protection against oxidative stress.

What is Multivitamins - vitamins B complex, C and E used for?

Multivitamins - vitamins B complex, C and E is indicated for Nutritional supplementation and disease prevention in general population, Potential reduction of cardiovascular disease risk.

Who makes Multivitamins - vitamins B complex, C and E?

Multivitamins - vitamins B complex, C and E is developed by Harvard School of Public Health (HSPH) (see full Harvard School of Public Health (HSPH) pipeline at /company/harvard-school-of-public-health-hsph).

What drug class is Multivitamins - vitamins B complex, C and E in?

Multivitamins - vitamins B complex, C and E belongs to the Vitamin supplement / Multivitamin class. See all Vitamin supplement / Multivitamin drugs at /class/vitamin-supplement-multivitamin.

What development phase is Multivitamins - vitamins B complex, C and E in?

Multivitamins - vitamins B complex, C and E is in Phase 3.

What are the side effects of Multivitamins - vitamins B complex, C and E?

Common side effects of Multivitamins - vitamins B complex, C and E include Gastrointestinal upset (nausea, diarrhea), Headache, Flushing (from niacin).

Related

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing