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Norditropin FlexPro pen · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| Norditropin® | EXPERIMENTAL | - |
| Genotropin® | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Norditropin® FlexPro® pen | DRUG | Administered as a single subcutaneous (s.c., under the skin) dose (4.0 mg) on 2 separate dosing visits (treatment periods). The 2 treatment periods will be separated by a 7-day washout period. |
| Genotropin Pen® | DRUG | Administered as a single subcutaneous dose (4.0 mg) on 2 separate dosing visits (treatment periods). The 2 treatment periods will be separated by a 7-day washout period. |
Inclusion Criteria: * Healthy subjects at trial entry with no previous exposure to recombinant human growth hormone or IGF-I (insulin-like growth factor-I) * Body mass index (BMI) 18.0-27.0 kg/m\^2 (both inclusive) * Considered generally healthy upon completion of medical history, physical examinat...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novo Nordisk A/S Sponsored ADR Class B | NVO | 2 | PHASE3 | Somapacitan, Norditropin FlexPro pen |
| Ascendis Pharma A/S | ASND | 1 | PHASE3 | Lonapegsomatropin |
Norditropin FlexPro pen is a delivery device for Norditropin, a somatropin (growth hormone) product developed by Novo Nordisk A/S for growth disorders. It is designed to let patients inject a prescribed dose of somatropin. The FlexPro pen is the injection pen format of the Norditropin brand.
Norditropin FlexPro pen is used to deliver Norditropin, a somatropin therapy, in the treatment of growth disorders. Somatropin is a growth hormone replacement. The pen is the administration device for the Norditropin product, which is prescribed for growth disorder indications in the endocrine therapeutic area.
Norditropin FlexPro pen is made by Novo Nordisk A/S, which trades under the ticker NVO. Novo Nordisk is the developer of the Norditropin brand of somatropin and the FlexPro pen delivery device.
Norditropin FlexPro pen is associated with Phase 1 clinical development. One Phase 1 trial of Norditropin has been completed, and no active trials are ongoing. The completed study was an active-controlled, randomized Phase 1 trial in healthy adult subjects.
Norditropin FlexPro pen is linked to one completed Phase 1 trial, NCT01943084, titled a trial to investigate the bioequivalence of Norditropin (somatropin) versus Genotropin (somatropin) in healthy adult subjects. It enrolled 32 participants in the United States, was randomized and active-controlled, and included healthy volunteers aged 18 years and older.
Yes, Norditropin FlexPro pen is also written as Norditropin FlexPro. The registered alternative name is Norditropin® FlexPro® pen. Both refer to the same Novo Nordisk somatropin injection pen product.