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folic acid multivitamin
folic acid multivitamin is a Vitamin Small molecule drug developed by National Institute of Neurological Disorders and Stroke (NINDS). It is currently in Phase 3 development for Prevention of birth defects of the brain and spine, Maintenance of healthy red blood cells.
Folic acid is a form of vitamin B9 that plays a crucial role in DNA synthesis and repair.
Folic acid is a form of vitamin B9 that plays a crucial role in DNA synthesis and repair. Used for Prevention of birth defects of the brain and spine, Maintenance of healthy red blood cells.
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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 | folic acid multivitamin |
|---|---|
| Sponsor | National Institute of Neurological Disorders and Stroke (NINDS) |
| Drug class | Vitamin |
| Modality | Small molecule |
| Therapeutic area | Nutritional supplement |
| Phase | Phase 3 |
Mechanism of action
Folic acid is essential for the production of red blood cells and the maintenance of healthy homocysteine levels in the blood. It also helps to prevent birth defects of the brain and spine. Additionally, folic acid is involved in the synthesis of nucleic acids and the repair of DNA damage.
Approved indications
- Prevention of birth defects of the brain and spine
- Maintenance of healthy red blood cells
Common side effects
- Gastrointestinal upset
Key clinical trials
- Chemo Brain Prehab Project (NA)
- The Benefits of Natural Medicine, Vitamin IV Therapy and Supplements: Maintaining Good Health Through Nature
- A Study to Gather Information About the Progress and Outcomes of Pregnancy in Women Using Various Vitamin Support Plans Before and During Pregnancy
- Swedish Iodine in Pregnancy and Development in Children (SWIDDICH) Study (NA)
- Use of Ritual Prenatal Multivitamins for Pregnancy (NA)
- Histidine Oral Supplementation as a Therapeutic Modality for Alzheimer's Disease (PHASE4)
- Adiposity and Iron Requirements in Pregnancy (NA)
- Study of Absorption Characteristics of Two Multivitamin Mineral Formulations (Gel vs. Tablet/Capsule) (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:
- folic acid multivitamin CI brief — competitive landscape report
- folic acid multivitamin updates RSS · CI watch RSS
- National Institute of Neurological Disorders and Stroke (NINDS) portfolio CI
Frequently asked questions about folic acid multivitamin
What is folic acid multivitamin?
How does folic acid multivitamin work?
What is folic acid multivitamin used for?
Who makes folic acid multivitamin?
What drug class is folic acid multivitamin in?
What development phase is folic acid multivitamin in?
What are the side effects of folic acid multivitamin?
Related
- Drug class: All Vitamin drugs
- Manufacturer: National Institute of Neurological Disorders and Stroke (NINDS) — full pipeline
- Therapeutic area: All drugs in Nutritional supplement
- Indication: Drugs for Prevention of birth defects of the brain and spine
- Indication: Drugs for Maintenance of healthy red blood cells
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing