Last reviewed 2026-04-23 · How we verify

Pre and Probiotic fortification

Johns Hopkins Bloomberg School of Public Health · Phase 3 active Small molecule

Pre and Probiotic fortification is a Small molecule drug developed by Johns Hopkins Bloomberg School of Public Health. It is currently in Phase 3 development for Malnutrition and micronutrient deficiency in resource-limited settings, Gastrointestinal health and immune function optimization.

Pre- and probiotic fortification enhances gut microbiota composition and function to improve digestive health and systemic immune responses.

Pre- and probiotic fortification enhances gut microbiota composition and function to improve digestive health and systemic immune responses. Used for Malnutrition and micronutrient deficiency in resource-limited settings, Gastrointestinal health and immune function optimization.

Likelihood of approval

59.3% 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).
Immunology slight uplift +1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.

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 name	Pre and Probiotic fortification
Sponsor	Johns Hopkins Bloomberg School of Public Health
Modality	Small molecule
Therapeutic area	Gastroenterology / Immunology
Phase	Phase 3

Mechanism of action

This intervention combines prebiotics (non-digestible food components that selectively feed beneficial bacteria) and probiotics (live beneficial microorganisms) to restore and maintain a healthy gut microbiome. By promoting the growth of beneficial bacteria and improving intestinal barrier function, the approach aims to enhance nutrient absorption, reduce pathogenic colonization, and modulate immune system activation.

Approved indications

Malnutrition and micronutrient deficiency in resource-limited settings
Gastrointestinal health and immune function optimization

Common side effects

Bloating
Flatulence
Mild gastrointestinal discomfort

Key clinical trials

Efficacy of Bifidus DR10 and Oligo Saccharides / Micronutrient Fortification of Milk (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:

Pre and Probiotic fortification CI brief — competitive landscape report
Pre and Probiotic fortification updates RSS · CI watch RSS
Johns Hopkins Bloomberg School of Public Health portfolio CI

Frequently asked questions about Pre and Probiotic fortification

What is Pre and Probiotic fortification?

Pre and Probiotic fortification is a Small molecule drug developed by Johns Hopkins Bloomberg School of Public Health, indicated for Malnutrition and micronutrient deficiency in resource-limited settings, Gastrointestinal health and immune function optimization.

How does Pre and Probiotic fortification work?

Pre- and probiotic fortification enhances gut microbiota composition and function to improve digestive health and systemic immune responses.

What is Pre and Probiotic fortification used for?

Pre and Probiotic fortification is indicated for Malnutrition and micronutrient deficiency in resource-limited settings, Gastrointestinal health and immune function optimization.

Who makes Pre and Probiotic fortification?

Pre and Probiotic fortification is developed by Johns Hopkins Bloomberg School of Public Health (see full Johns Hopkins Bloomberg School of Public Health pipeline at /company/johns-hopkins-bloomberg-school-of-public-health).

What development phase is Pre and Probiotic fortification in?

Pre and Probiotic fortification is in Phase 3.

What are the side effects of Pre and Probiotic fortification?

Common side effects of Pre and Probiotic fortification include Bloating, Flatulence, Mild gastrointestinal discomfort.

Manufacturer: Johns Hopkins Bloomberg School of Public Health — full pipeline
Therapeutic area: All drugs in Gastroenterology / Immunology
Indication: Drugs for Malnutrition and micronutrient deficiency in resource-limited settings
Indication: Drugs for Gastrointestinal health and immune function optimization

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