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CT Gel

Stiefel, a GSK Company · Phase 3 active Small molecule Under review

CT Gel is a Topical antimicrobial agent Small molecule drug developed by Stiefel, a GSK Company. It is currently in Phase 3 development for Bacterial skin infections or colonization (specific indication pending phase 3 completion).

CT Gel is a topical antimicrobial gel formulation designed to reduce bacterial colonization and biofilm formation on skin surfaces.

CT Gel is a small molecule modality, specifically a compound known as CT 2584. It is being studied in various clinical trials for conditions including acute stroke, hypertensive intracerebral hemorrhage, prostate cancer, and metastatic castration-resistant prostate cancer.

Likelihood of approval
61.3% 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).
  • Big-pharma sponsor +3.0pp
    Stiefel, a GSK Company is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
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 nameCT Gel
SponsorStiefel, a GSK Company
Drug classTopical antimicrobial agent
ModalitySmall molecule
Therapeutic areaDermatology
PhasePhase 3

Mechanism of action

CT Gel likely contains chlortetracycline or a similar broad-spectrum antimicrobial agent in a gel vehicle optimized for topical delivery. The formulation is intended to provide sustained antimicrobial activity against pathogenic bacteria while maintaining skin tolerability for chronic or recurrent infections.

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 CT Gel

What is CT Gel?

CT Gel is a Topical antimicrobial agent drug developed by Stiefel, a GSK Company, indicated for Bacterial skin infections or colonization (specific indication pending phase 3 completion).

How does CT Gel work?

CT Gel is a topical antimicrobial gel formulation designed to reduce bacterial colonization and biofilm formation on skin surfaces.

What is CT Gel used for?

CT Gel is indicated for Bacterial skin infections or colonization (specific indication pending phase 3 completion).

Who makes CT Gel?

CT Gel is developed by Stiefel, a GSK Company (see full Stiefel, a GSK Company pipeline at /company/stiefel-a-gsk-company).

What drug class is CT Gel in?

CT Gel belongs to the Topical antimicrobial agent class. See all Topical antimicrobial agent drugs at /class/topical-antimicrobial-agent.

What development phase is CT Gel in?

CT Gel is in Phase 3.

What are the side effects of CT Gel?

Common side effects of CT Gel include Local skin irritation, Contact dermatitis, Erythema.

Related

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