Last reviewed 2026-05-30 · How we verify

Gentian violet 0.00165% solution

Kamuzu University of Health Sciences · Phase 3 active Small molecule Under review Quality 0/100

Gentian violet 0.00165% solution is a Triphenylmethane dye antimicrobial Small molecule drug developed by Kamuzu University of Health Sciences. It is currently in Phase 3 development for Topical treatment of bacterial and fungal skin infections, Oral candidiasis (thrush), Wound antisepsis and disinfection.

Gentian violet is a triphenylmethane dye that exerts antimicrobial and antifungal effects by intercalating into microbial DNA and disrupting cellular function.

Gentian violet 0.00165% solution is a small molecule that inhibits DNA, classified as an inhibitor. It has been studied as a treatment for oral candidiasis and HIV-1 infection in clinical trials.

Likelihood of approval

60.3% 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).
Anti-infectives pathway favourability +2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.

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 name	Gentian violet 0.00165% solution
Sponsor	Kamuzu University of Health Sciences
Drug class	Triphenylmethane dye antimicrobial
Modality	Small molecule
Therapeutic area	Infectious Disease / Dermatology
Phase	Phase 3

Mechanism of action

Gentian violet (crystal violet) is a cationic dye that binds to nucleic acids and proteins in microorganisms, inhibiting their growth and reproduction. It has broad-spectrum activity against bacteria, fungi, and some parasites, making it useful as a topical antiseptic and antimicrobial agent. The dye's mechanism involves disruption of microbial cell membranes and interference with essential cellular processes.

Approved indications

Topical treatment of bacterial and fungal skin infections
Oral candidiasis (thrush)
Wound antisepsis and disinfection

Common side effects

Skin staining/discoloration
Local irritation or burning
Allergic contact dermatitis

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.

Source	Used for
ClinicalTrials.gov	Trial 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:

Gentian violet 0.00165% solution CI brief — competitive landscape report
Gentian violet 0.00165% solution updates RSS · CI watch RSS
Kamuzu University of Health Sciences portfolio CI

Frequently asked questions about Gentian violet 0.00165% solution

What is Gentian violet 0.00165% solution?

Gentian violet 0.00165% solution is a Triphenylmethane dye antimicrobial drug developed by Kamuzu University of Health Sciences, indicated for Topical treatment of bacterial and fungal skin infections, Oral candidiasis (thrush), Wound antisepsis and disinfection.

How does Gentian violet 0.00165% solution work?

Gentian violet is a triphenylmethane dye that exerts antimicrobial and antifungal effects by intercalating into microbial DNA and disrupting cellular function.

What is Gentian violet 0.00165% solution used for?

Gentian violet 0.00165% solution is indicated for Topical treatment of bacterial and fungal skin infections, Oral candidiasis (thrush), Wound antisepsis and disinfection.

Who makes Gentian violet 0.00165% solution?

Gentian violet 0.00165% solution is developed by Kamuzu University of Health Sciences (see full Kamuzu University of Health Sciences pipeline at /company/kamuzu-university-of-health-sciences).

What drug class is Gentian violet 0.00165% solution in?

Gentian violet 0.00165% solution belongs to the Triphenylmethane dye antimicrobial class. See all Triphenylmethane dye antimicrobial drugs at /class/triphenylmethane-dye-antimicrobial.

What development phase is Gentian violet 0.00165% solution in?

Gentian violet 0.00165% solution is in Phase 3.

What are the side effects of Gentian violet 0.00165% solution?

Common side effects of Gentian violet 0.00165% solution include Skin staining/discoloration, Local irritation or burning, Allergic contact dermatitis.

Drug class: All Triphenylmethane dye antimicrobial drugs
Manufacturer: Kamuzu University of Health Sciences — full pipeline
Therapeutic area: All drugs in Infectious Disease / Dermatology
Indication: Drugs for Topical treatment of bacterial and fungal skin infections
Indication: Drugs for Oral candidiasis (thrush)
Indication: Drugs for Wound antisepsis and disinfection

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