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Bredinin (MIZORIBINE)

Phase 3 active Small molecule Under review Quality 10/100

Bredinin (generic name: MIZORIBINE) is a mizoribine drug. It is currently in Phase 3 development.

Mizoribine blocks the production of guanine nucleotides by inhibiting the enzyme inosine monophosphate dehydrogenase.

Bredinin is a small molecule inhibitor of inosine-5'-monophosphate dehydrogenase (IMPDH). It has been studied in clinical trials for various conditions, including kidney transplant recipients, BK virus, kidney transplant immunosuppression, rheumatoid arthritis, and lupus nephritis.

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 nameMIZORIBINE
Drug classmizoribine
ModalitySmall molecule
Therapeutic areaImmunology
PhasePhase 3

Mechanism of action

Think of it like a roadblock in a factory. Guanine nucleotides are like the raw materials needed to build important molecules in our cells. By blocking the enzyme that makes these raw materials, mizoribine slows down the production of these molecules, which can help to reduce inflammation and other symptoms of autoimmune diseases.

Approved indications

No approved indications tracked.

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 Bredinin

What is Bredinin?

Bredinin (MIZORIBINE) is a mizoribine drug.

How does Bredinin work?

Mizoribine blocks the production of guanine nucleotides by inhibiting the enzyme inosine monophosphate dehydrogenase.

What is the generic name of Bredinin?

MIZORIBINE is the generic (nonproprietary) name of Bredinin.

What drug class is Bredinin in?

Bredinin belongs to the mizoribine class. See all mizoribine drugs at /class/mizoribine.

What development phase is Bredinin in?

Bredinin is in Phase 3.

What are the side effects of Bredinin?

Common side effects of Bredinin include Cytomegalovirus infection, Osteonecrosis, Kidney transplant rejection, N-telopeptide urine increased, Pharyngitis, Hypocomplementaemia.

Related

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