Last reviewed 2026-04-23 · How we verify

Labinic (R) probiotic mixture

Haydom Lutheran Hospital · Phase 3 active Biologic

Labinic (R) probiotic mixture is a Probiotic Biologic drug developed by Haydom Lutheran Hospital. It is currently in Phase 3 development for Gastrointestinal disorders associated with dysbiosis, Infectious diarrhea or antibiotic-associated diarrhea.

Labinic is a probiotic mixture that restores beneficial gut microbiota to improve intestinal health and immune function.

Labinic is a probiotic mixture that restores beneficial gut microbiota to improve intestinal health and immune function. Used for Gastrointestinal disorders associated with dysbiosis, Infectious diarrhea or antibiotic-associated diarrhea.

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	Labinic (R) probiotic mixture
Sponsor	Haydom Lutheran Hospital
Drug class	Probiotic
Modality	Biologic
Therapeutic area	Gastroenterology / Immunology
Phase	Phase 3

Mechanism of action

The product contains live beneficial bacterial strains that colonize the gastrointestinal tract, promoting a healthy microbiome composition. By restoring eubiotic conditions, it may enhance intestinal barrier function, reduce pathogenic bacterial overgrowth, and modulate local and systemic immune responses.

Approved indications

Gastrointestinal disorders associated with dysbiosis
Infectious diarrhea or antibiotic-associated diarrhea

Common side effects

Gastrointestinal disturbance
Bloating
Flatulence

Key clinical trials

Use of Probiotics to Reduce Infections, Death and ESBL Colonisation (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:

Labinic (R) probiotic mixture CI brief — competitive landscape report
Labinic (R) probiotic mixture updates RSS · CI watch RSS
Haydom Lutheran Hospital portfolio CI

Frequently asked questions about Labinic (R) probiotic mixture

What is Labinic (R) probiotic mixture?

Labinic (R) probiotic mixture is a Probiotic drug developed by Haydom Lutheran Hospital, indicated for Gastrointestinal disorders associated with dysbiosis, Infectious diarrhea or antibiotic-associated diarrhea.

How does Labinic (R) probiotic mixture work?

Labinic is a probiotic mixture that restores beneficial gut microbiota to improve intestinal health and immune function.

What is Labinic (R) probiotic mixture used for?

Labinic (R) probiotic mixture is indicated for Gastrointestinal disorders associated with dysbiosis, Infectious diarrhea or antibiotic-associated diarrhea.

Who makes Labinic (R) probiotic mixture?

Labinic (R) probiotic mixture is developed by Haydom Lutheran Hospital (see full Haydom Lutheran Hospital pipeline at /company/haydom-lutheran-hospital).

What drug class is Labinic (R) probiotic mixture in?

Labinic (R) probiotic mixture belongs to the Probiotic class. See all Probiotic drugs at /class/probiotic.

What development phase is Labinic (R) probiotic mixture in?

Labinic (R) probiotic mixture is in Phase 3.

What are the side effects of Labinic (R) probiotic mixture?

Common side effects of Labinic (R) probiotic mixture include Gastrointestinal disturbance, Bloating, Flatulence.

Drug class: All Probiotic drugs
Manufacturer: Haydom Lutheran Hospital — full pipeline
Therapeutic area: All drugs in Gastroenterology / Immunology
Indication: Drugs for Gastrointestinal disorders associated with dysbiosis
Indication: Drugs for Infectious diarrhea or antibiotic-associated diarrhea

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