P-113D

Summary

P-113D is a 12-mer D-amino acid analogue of the salivary peptide histatin-5, engineered for enhanced stability and broad-spectrum antimicrobial activity. It has been investigated primarily for oral candidiasis and periodontal infections, demonstrating activity against Candida species and oral pathogens including Porphyromonas gingivalis.

Mechanism of Action

Derived from histatin-5, P-113D disrupts microbial cell membranes via electrostatic interactions with negatively charged phospholipids, leading to membrane depolarization and cell death. It also inhibits intracellular targets including mitochondrial function in fungi. The D-amino acid configuration confers resistance to proteolytic degradation.

Routes of Administration

Goals & Uses

• Broad-spectrum antifungal activityAntifungalModerate
• Biofilm disruptionAntimicrobialLow
• Periodontal infection controlAntibacterialLow
• Oral candidiasis treatmentAntifungalModerate

Contraindications

• Known hypersensitivity to histatin peptidesAllergyHigh

Adverse Effects

• Taste disturbanceSensoryUncommonAltered sense of taste
• Hypersensitivity reactionImmunologicRare
• Local oral irritationLocal ReactionUncommon

Drug Interactions

• Zinc-containing productsLow

Population Constraints

• Pediatric patientsAgeRelative
• Severely immunocompromised patients with systemic candidiasisDisease SeverityRelative
• Pregnant or lactating womenReproductiveRelative

Regulatory Status

• European UnionUnknownNo EMA approval or formal regulatory designation identified.
• United StatesInvestigationalInvestigated under IND; Phase II trials conducted; no NDA filed or approved.
• United KingdomUnknownNo MHRA approval identified.

No regulatory approval in any jurisdiction. Investigated in early-phase clinical trials for oral candidiasis in HIV-positive patients. Development has remained at investigational/research stage.

Evidence & Sources

No sources recorded yet.