PDRN (Polydeoxyribonucleotide)
/ Polydeoxyribonucleotide; salmon-DNA fragments (50 to 1500 base pairs typical); A2A adenosine receptor agonistALIAS · PDRN · Polydeoxyribonucleotide · Placentex Integro (trade — Italy)
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Tier 2. Polydeoxyribonucleotide (PDRN) — a mixture of low-molecular-weight DNA fragments derived from salmon trout sperm — is approved as a medical product in Italy (Placentex Integro) and used clinically in Korea, Romania, and several other countries for wound healing, skin regeneration, and intra-articular use in osteoarthritis. Not FDA-approved in the United States. Phase 2/3 trials in osteoarthritis and chronic wounds support the regional uses; cosmetic 'salmon DNA' or 'polynucleotide' injectables are a distinct product category with their own market-driven evidence base.
PDRN is not a single molecule but a defined-process preparation of low-molecular-weight DNA fragments (typically 50 to 1500 base pairs) extracted from salmon trout (Oncorhynchus mykiss) gonadal tissue and purified to remove proteins and lipopolysaccharide. The proposed mechanism centres on agonism of the A2A adenosine receptor by adenosine and short oligonucleotides released from the polymer in tissue, driving anti-inflammatory and pro-angiogenic gene-expression programmes. Salvage-pathway nucleoside contributions and direct effects on growth-factor expression (VEGF, FGF-2) have also been reported in preclinical work.
Tier 2. Squadrito 2017 reported a Phase 2 trial of intra-articular PDRN in knee osteoarthritis with WOMAC pain and function improvements over the trial period. Italian and Korean clinical literature includes additional Phase 2/3 trials in chronic wounds, diabetic foot ulcers, post-surgical scarring, and intra-articular indications. Veronesi 2017 (review) summarises the preclinical and clinical evidence base. Western multicentre Phase 3 replication for an FDA pathway has not been pursued at scale.
Intra-articular PDRN in published trials has produced injection-site discomfort and transient inflammatory flare; serious adverse events have been infrequent. Salmon-source allergenicity is a theoretical concern that has produced occasional case reports but not a major systemic signal. Cosmetic use of 'polynucleotide' injectables (related but variably defined products) has produced dermal nodule and granuloma case reports in the dermatology literature.
Regulatory status
- FDA status:
- Not FDA-approved
- Compounding:
- Compounding eligibility ambiguous
The product class is heterogeneous: pharmaceutical PDRN (Placentex Integro), cosmetic 'polynucleotide' injectables (multiple brands), and online-sold 'PDRN' from peptide suppliers are not interchangeable, and the published controlled-trial evidence base attaches to specific manufactured products rather than to the class. The A2A-agonism mechanism is an inference from preclinical signalling work and is not directly demonstrated as the clinically relevant mode of action. Western regulatory evaluation of PDRN for an FDA pathway has not occurred, and the trial literature is concentrated in Italy and Korea.