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MAM01 900 mg

Gates Medical Research Institute · Phase 1 active Biologic Quality 0/100

MAM01 900 mg is a Biologic drug developed by Gates Medical Research Institute. It is currently in Phase 1 development.

MAM01 is a novel investigational drug developed by Gates Medical Research Institute. It has completed Phase 1 trials assessing safety, tolerability, pharmacokinetics, and protective efficacy in healthy adults. No FDA label is available, and further clinical development is required to establish its therapeutic potential.

Likelihood of approval
9.6% vs 9.6% industry baseline
If approved by FDA: likely 2033–2036
Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission
Confidence: Medium
Why this estimate
  • Baseline phase 1 → approval rate +9.6pp
    Industry-wide phase 1 drugs reach approval ~9.6% 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 2033–2036 —
EMA EU 2034–2037 +0.7 yr
MHRA GB 2034–2037 +0.7 yr
Health Canada CA 2034–2038 +0.9 yr
TGA AU 2034–2038 +1.2 yr
PMDA JP 2034–2038 +1.5 yr
NMPA CN 2035–2039 +2.3 yr
MFDS KR 2034–2038 +1.4 yr
CDSCO IN 2034–2039 +1.8 yr
ANVISA BR 2035–2039 +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 nameMAM01 900 mg
SponsorGates Medical Research Institute
ModalityBiologic
PhasePhase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

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 MAM01 900 mg

What is MAM01 900 mg?

MAM01 900 mg is a Biologic drug developed by Gates Medical Research Institute.

Who makes MAM01 900 mg?

MAM01 900 mg is developed by Gates Medical Research Institute (see full Gates Medical Research Institute pipeline at /company/gates-medical-research-institute).

What development phase is MAM01 900 mg in?

MAM01 900 mg is in Phase 1.

Related

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