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supplementation, food

National Heart, Lung, and Blood Institute (NHLBI) · Phase 3 active Small molecule Under review

supplementation, food is a Small molecule drug developed by National Heart, Lung, and Blood Institute (NHLBI). It is currently in Phase 3 development for General nutritional support.

This drug works by providing essential nutrients and vitamins through supplementation.

Oral nutritional supplements have been studied for various conditions, including malnutrition, surgery complications, physical disability, Alzheimer's disease, and non-alcoholic fatty liver disease, primarily in children and adults undergoing surgery. These supplements can also be used as a component in vaccines, such as the yellow fever vaccine, to induce an immune response.

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 namesupplementation, food
SponsorNational Heart, Lung, and Blood Institute (NHLBI)
ModalitySmall molecule
Therapeutic areaNutrition
PhasePhase 3

Mechanism of action

The exact molecular target or receptor is unknown, but it is believed to help maintain overall health and well-being by addressing nutritional deficiencies.

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

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Frequently asked questions about supplementation, food

What is supplementation, food?

supplementation, food is a Small molecule drug developed by National Heart, Lung, and Blood Institute (NHLBI), indicated for General nutritional support.

How does supplementation, food work?

This drug works by providing essential nutrients and vitamins through supplementation.

What is supplementation, food used for?

supplementation, food is indicated for General nutritional support.

Who makes supplementation, food?

supplementation, food is developed by National Heart, Lung, and Blood Institute (NHLBI) (see full National Heart, Lung, and Blood Institute (NHLBI) pipeline at /company/national-heart-lung-and-blood-institute-nhlbi).

What development phase is supplementation, food in?

supplementation, food is in Phase 3.

What are the side effects of supplementation, food?

Common side effects of supplementation, food include Gastrointestinal upset.

Related

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