Somatrogon

Unassigned

New Medicines

Growth hormone deficiency in adults - long-acting formulation of somatotropin

Information

New molecular entity
Pfizer
Pfizer

Development and Regulatory status

None
Phase III Clinical Trials
Phase III Clinical Trials
Yes
Yes

Category

A long-acting, proprietary formulation of somatropin, for once weekly or bi-monthly administration. Disposable pre-filled pen. The technology used to develop long-acting somatropin is based on the carboxyl terminal peptide (CTP) that has been shown to extend the active time of therapeutic proteins in the body without increasing toxicity or reducing biological activity.
Growth-hormone deficiency affected approximately 4 in 10,000 people in the European Union (EU) [3].
Growth hormone deficiency in adults - long-acting formulation of somatotropin
Subcutaneous

Growth hormone deficiency in children

Information

Licence extension / variation
Pfizer
Pfizer

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials
Yes
Yes

Category

A long-acting, proprietary formulation of somatropin, for once weekly or bi-monthly administration. Disposable pre-filled pen.
Growth-hormone deficiency affected approximately 4 in 10,000 people in the European Union (EU) [1].
Growth hormone deficiency in children
Subcutaneous injection