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SanaCutan Basiscreme

Infectopharm Arzneimittel GmbH · Phase 3 active Small molecule Under review

SanaCutan Basiscreme is a Small molecule drug developed by Infectopharm Arzneimittel GmbH. It is currently in Phase 3 development for Dry skin and skin barrier dysfunction, Irritated or damaged skin conditions.

SanaCutan Basiscreme is a topical emollient and skin barrier repair cream that hydrates and protects damaged or irritated skin.

SanaCutan Basiscreme is a moisturizer used in a clinical trial to prevent symptoms of atopic dermatitis in early childhood. It has been studied in infants and newborns with atopic dermatitis.

Likelihood of approval
58.3% 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).
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 nameSanaCutan Basiscreme
SponsorInfectopharm Arzneimittel GmbH
ModalitySmall molecule
Therapeutic areaDermatology
PhasePhase 3

Mechanism of action

This is a basic skincare formulation designed to restore and maintain the skin barrier function through occlusive and humectant ingredients. It provides symptomatic relief for dry, irritated, or compromised skin by reducing transepidermal water loss and supporting natural skin healing processes.

Approved indications

Common side effects

No common side effects on file.

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 SanaCutan Basiscreme

What is SanaCutan Basiscreme?

SanaCutan Basiscreme is a Small molecule drug developed by Infectopharm Arzneimittel GmbH, indicated for Dry skin and skin barrier dysfunction, Irritated or damaged skin conditions.

How does SanaCutan Basiscreme work?

SanaCutan Basiscreme is a topical emollient and skin barrier repair cream that hydrates and protects damaged or irritated skin.

What is SanaCutan Basiscreme used for?

SanaCutan Basiscreme is indicated for Dry skin and skin barrier dysfunction, Irritated or damaged skin conditions.

Who makes SanaCutan Basiscreme?

SanaCutan Basiscreme is developed by Infectopharm Arzneimittel GmbH (see full Infectopharm Arzneimittel GmbH pipeline at /company/infectopharm-arzneimittel-gmbh).

What development phase is SanaCutan Basiscreme in?

SanaCutan Basiscreme is in Phase 3.

Related

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