Clinical Trials

Multiple clinical trials sponsored by the biopharmaceutical company TargeGen have evaluated TG100-115 for cardiovascular indications, primarily myocardial infarction. These completed, early-stage studies—designed as randomized, double-blind, placebo-controlled Phase 1 and Phase 2 investigations—focused on assessing the safety profile and early biological efficacy of single or escalating doses. Currently, participant recruitment across the trial portfolio is marked as completed, concluding the formal clinical evaluation of TG100-115.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT00103350 COMPLETED
Myocardial Infarction
TargeGen
 2005-01 PHASE1; PHASE2
NCT00103350 Completed
Myocardial Infarction
TargeGen
 2005-01 Phase 1|Phase 2

(data from https://clinicaltrials.gov, updated on 2008-05-20)

Check the TG100-115 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

TG100-115 selectively binds to and inhibits phosphoinositide 3-kinase gamma (PI3Kγ) and delta (PI3Kδ) isoforms with IC50 values of 83 nM and 235 nM, respectively, thereby blocking downstream lipid kinase activity and intracellular mediator signaling in immune cells. By dampening leukocyte recruitment, vascular permeability, and tissue inflammation, this targeted enzymatic inhibition reduces ischemic myocardial damage in conditions such as myocardial infarction.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.