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EB01 Cream 2.0%

Edesa Biotech Inc. · Phase 2 active Small molecule

EB01 Cream 2.0% is a corticosteroid Small molecule drug developed by Edesa Biotech Inc.. It is currently in Phase 2 development for Moderate to severe eczema, Moderate to severe psoriasis.

EB01 Cream 2.0% is a topical corticosteroid used to reduce inflammation and itching.

EB01 Cream 2.0% is a topical corticosteroid used to reduce inflammation and itching. Used for Moderate to severe eczema, Moderate to severe psoriasis.

Likelihood of approval
15.3% vs 15.3% industry baseline
If approved by FDA: likely 2031–2034
Steps remaining: Phase 3 → NDA/BLA submission
Confidence: Medium
Why this estimate
  • Baseline phase 2 → approval rate +15.3pp
    Industry-wide phase 2 drugs reach approval ~15.3% 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 2031–2034 —
EMA EU 2032–2035 +0.7 yr
MHRA GB 2032–2035 +0.7 yr
Health Canada CA 2032–2036 +0.9 yr
TGA AU 2032–2036 +1.2 yr
PMDA JP 2032–2036 +1.5 yr
NMPA CN 2033–2037 +2.3 yr
MFDS KR 2032–2036 +1.4 yr
CDSCO IN 2032–2037 +1.8 yr
ANVISA BR 2033–2037 +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 nameEB01 Cream 2.0%
SponsorEdesa Biotech Inc.
Drug classcorticosteroid
ModalitySmall molecule
Therapeutic areaDermatology
PhasePhase 2

Mechanism of action

It works by inhibiting the production of pro-inflammatory cytokines and reducing the migration of inflammatory cells to the affected area. This leads to a decrease in inflammation and itching, providing relief to patients with skin conditions such as eczema or psoriasis.

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 EB01 Cream 2.0%

What is EB01 Cream 2.0%?

EB01 Cream 2.0% is a corticosteroid drug developed by Edesa Biotech Inc., indicated for Moderate to severe eczema, Moderate to severe psoriasis.

How does EB01 Cream 2.0% work?

EB01 Cream 2.0% is a topical corticosteroid used to reduce inflammation and itching.

What is EB01 Cream 2.0% used for?

EB01 Cream 2.0% is indicated for Moderate to severe eczema, Moderate to severe psoriasis.

Who makes EB01 Cream 2.0%?

EB01 Cream 2.0% is developed by Edesa Biotech Inc. (see full Edesa Biotech Inc. pipeline at /company/edesa-biotech-inc).

What drug class is EB01 Cream 2.0% in?

EB01 Cream 2.0% belongs to the corticosteroid class. See all corticosteroid drugs at /class/corticosteroid.

What development phase is EB01 Cream 2.0% in?

EB01 Cream 2.0% is in Phase 2.

What are the side effects of EB01 Cream 2.0%?

Common side effects of EB01 Cream 2.0% include Skin atrophy, Hypersensitivity reactions.

Related

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