A single vial freeze-dried kit formulation for preparation of three patients' dose of [^99mTc]TRODAT-1has been developed for early diagnos is of Parkinson's disease (PD). Kits were evaluated to ascertain the purity, stability and batch to batch variations. Preclinical evaluation was carried out in laboratory animals and clinical imaging was performed in human patients with PD.The labeling yield and purity of [^99mTc]TRODAT-1was > 90%. Swiss mice showed retention of [^99mTc]TRODAT-1 in the mid brain region.Clinicalstudies showed decreased striatal uptake with increasing severity of PD.