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SD-101 Dermal Cream (6%)

Scioderm, Inc. · Phase 3 active Small molecule Under review

SD-101 Dermal Cream (6%) is a Small molecule drug developed by Scioderm, Inc.. It is currently in Phase 3 development for Dermatological indication (specific indication not publicly disclosed). Also known as: SD-101, SD-101-6.0, Zorblisa.

SD-101 is a topical dermal cream formulation designed to treat skin conditions through a proprietary mechanism not publicly disclosed in detail.

SD-101 Dermal Cream (6%) is a topical treatment being studied for Epidermolysis Bullosa (EB) in clinical trials. The exact mechanism of action of SD-101 Dermal Cream is currently unknown.

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 nameSD-101 Dermal Cream (6%)
Also known asSD-101, SD-101-6.0, Zorblisa
SponsorScioderm, Inc.
ModalitySmall molecule
Therapeutic areaDermatology
PhasePhase 3

Mechanism of action

SD-101 at 6% concentration is being developed by Scioderm, Inc. as a dermatological therapeutic. The specific molecular mechanism and active pharmaceutical ingredient details are not widely available in public literature, limiting detailed mechanistic characterization at this phase of development.

Approved indications

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 SD-101 Dermal Cream (6%)

What is SD-101 Dermal Cream (6%)?

SD-101 Dermal Cream (6%) is a Small molecule drug developed by Scioderm, Inc., indicated for Dermatological indication (specific indication not publicly disclosed).

How does SD-101 Dermal Cream (6%) work?

SD-101 is a topical dermal cream formulation designed to treat skin conditions through a proprietary mechanism not publicly disclosed in detail.

What is SD-101 Dermal Cream (6%) used for?

SD-101 Dermal Cream (6%) is indicated for Dermatological indication (specific indication not publicly disclosed).

Who makes SD-101 Dermal Cream (6%)?

SD-101 Dermal Cream (6%) is developed by Scioderm, Inc. (see full Scioderm, Inc. pipeline at /company/scioderm-inc).

Is SD-101 Dermal Cream (6%) also known as anything else?

SD-101 Dermal Cream (6%) is also known as SD-101, SD-101-6.0, Zorblisa.

What development phase is SD-101 Dermal Cream (6%) in?

SD-101 Dermal Cream (6%) is in Phase 3.

Related

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