AC-SDKP (TB-500 Fragment)safety profile & UK regulatory status

This page summarises the published safety profile, contraindications, formulation interactions, and UK regulatory status for AC-SDKP (TB-500 Fragment) as reported in the pre-clinical research literature. It is a research-orientation reference and not a clinical safety assessment. AC-SDKP (TB-500 Fragment) is not licensed as a medicine in the United Kingdom and may not be supplied or administered to humans outside an authorised clinical-trial framework.

Safety profile

AC-SDKP is an endogenous peptide circulating in human plasma at concentrations in the low nanomolar range. Its endogenous status is generally regarded as favouring a high baseline safety profile, and acute toxicology studies in rodents have not identified dose-limiting adverse effects at concentrations substantially above those achievable by ACE-inhibitor-mediated elevation. The principal theoretical concern in a research context is the haematopoietic suppressive activity: at concentrations well above physiological, AC-SDKP inhibits pluripotent stem-cell proliferation, and sustained supraphysiological exposure could theoretically impair regenerative haematopoiesis. In practice, this concern has not translated into observed cytopenias in any published animal study using therapeutic-range dosing. Because AC-SDKP is a tetrapeptide of 487 Da, immunogenicity in humans is considered negligible — it is well below the threshold at which peptides typically elicit antibody responses, and its endogenous nature means immune tolerance is expected. Sterility and endotoxin content of research-grade preparations remain the dominant practical safety variables, as with all injectable research peptides. Batch-to-batch verification by HPLC and mass spectrometry, and endotoxin testing by limulus amebocyte lysate (LAL) assay, are standard due-diligence expectations. Long-term human systemic dosing data do not exist outside of the indirect exposure provided by ACE-inhibitor therapy. The effects of bolus exogenous AC-SDKP on reproductive endpoints, oncogenic risk, or immune competence in humans remain entirely unstudied.

UK regulatory status

AC-SDKP (Goralatide) is not authorised as a medicinal product by the UK Medicines and Healthcare products Regulatory Agency (MHRA) and has not received a marketing authorisation in any jurisdiction as of the current date. It is not a controlled substance under the Misuse of Drugs Act 1971 or the Misuse of Drugs Regulations 2001. AC-SDKP is not explicitly named on the World Anti-Doping Agency (WADA) Prohibited List; however, WADA's S0 category ('Non-Approved Substances') covers any pharmacological substance not approved by any regulatory authority for human therapeutic use, which would encompass AC-SDKP administered for performance or recovery purposes in competitive sport. Researchers should consult the current annual WADA Prohibited List for the definitive position. Possession of AC-SDKP for bona fide in-vitro or ex-vivo laboratory research purposes is unrestricted in the United Kingdom. Supply for human administration, or administration to a third party, would likely engage medicines-regulation provisions and should not be undertaken outside of an authorised clinical trial framework. No UK enforcement actions concerning AC-SDKP supply specifically are known to this publication.

What 'research-use-only' means in the UK

The UK regulatory position on research peptides sits across four distinct frameworks: MHRA medicines licensing, the Human Medicines Regulations 2012, the Misuse of Drugs Act 1971, and the WADA Prohibited List. AC-SDKP (TB-500 Fragment) is not an MHRA-licensed medicine; possession for bona fide in-vitro or ex-vivo laboratory research is generally lawful, while supply or administration to humans engages the Human Medicines Regulations and is generally an offence. For animal-research use, additional permissions are required under the Animals (Scientific Procedures) Act 1986 (ASPA).

For the comprehensive UK regulatory reference covering all four frameworks, see the UK research peptide regulation 2026 reference.

Practical safety considerations for research

Sterility and endotoxin content of research-grade preparations remain the dominant practical safety variables for any injectable in-vivo work, regardless of the intrinsic safety profile of the active peptide. Batch-to-batch verification of HPLC purity and identity (by mass spectrometry where possible) and endotoxin testing by limulus amebocyte lysate (LAL) assay or recombinant Factor C (rFC) assay are standard due-diligence expectations. For research with vertebrate animals in the UK, ASPA project and personal licences are mandatory and the work must pass a local Animal Welfare and Ethical Review Body assessment.

For full AC-SDKP (TB-500 Fragment) research context including mechanism, study citations, and references, see the main AC-SDKP (TB-500 Fragment) research profile. For dosing and pharmacokinetic context, see the dosing reference and half-life reference pages.