Drug intelligence / Profile preview

somatropin + ethinyl estradiol

Development stage
Phase 2
Lead developer
Eli Lilly
Modality
Small Molecules, Recombinant Proteins and Enzymes
Administration
Subcutaneous, Oral
01

Overview

This combination therapy consists of recombinant human growth hormone (somatropin) and ultra-low-dose ethinyl estradiol, specifically evaluated in a landmark clinical trial (NCT00001221) co-sponsored by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and Eli Lilly. Somatropin, a biologic, acts as an agonist at the growth hormone receptor to stimulate linear growth and increase insulin-like growth factor 1 (IGF-1) levels. Ethinyl estradiol, a synthetic small molecule estrogen, is administered at ultra-low doses (25-50 ng/kg/day) to mimic early physiological prepubertal levels. The combination is designed to address the characteristic short stature and ovarian dysgenesis associated with Turner syndrome, with the trial demonstrating a synergistic effect that increases final adult height by approximately 5.0 cm compared to untreated patients.

Other names
Growth Hormone and Ethinyl Estradiol for Adult Height in Turner Syndromerecombinant human growth hormone + ethinyl estradiolrhGH + ethinyl estradiol
02

Targets

ESR1 (ERα)ESR2 (ERβ)GHR (Growth hormone receptor)

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