NORDITROPIN FLEXPRO (somatropin)
NORDITROPIN FLEXPRO is indicated for the treatment of Growth Hormone Deficiency; Short Stature; Noonan Syndrome; Turner Syndrome; Small for Gestational Age; Prader-Willi Syndrome.
How NORDITROPIN FLEXPRO Works
Somatropin binds to dimeric growth hormone receptors on the cell membranes of target tissues, triggering intracellular signal transduction. This interaction induces the production of growth hormone-dependent proteins, such as IGF-1, which mediate various tissue and metabolic effects. In pediatric patients, the drug stimulates skeletal growth by acting on the growth plates of long bones and increasing cellular protein synthesis. It also regulates metabolic processes, including lipolysis, protein synthesis, and hepatic glucose output.
Details
- Status
- Prescription
- First Approved
- 2000-06-20
- Patent Cliff
- 2014
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
NORDITROPIN FLEXPRO Approval History
What NORDITROPIN FLEXPRO Treats
6 indicationsNORDITROPIN FLEXPRO is approved for 6 conditions since its original approval in 2000. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Growth Hormone Deficiency
- Short Stature
- Noonan Syndrome
- Turner Syndrome
- Small for Gestational Age
- Prader-Willi Syndrome
NORDITROPIN FLEXPRO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
29 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05690386 | ASND0034 | Ph 2 | active not recruiting | A Trial to Investigate Different Doses of Lonapegsomatropin Compared to Somatropin in Individuals With Turner Syndrome |
| NCT04867317 GRIT | 2018 | Ph 3 | recruiting | Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD) |
| NCT02968004 results posted | CP-4-006 | Ph 3 | completed | Safety and Efficacy Phase 3 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children |
| NCT05382637 results posted | STUDY00000211 | Ph 2 | active not recruiting | Growth Hormone in a Patient With a Dominant-Negative GHR Mutation |
| NCT03554265 results posted | 17-0313 | Ph 3 | completed | Brain and Gut Plasticity in Mild TBI or Post-acute COVID Syndrome Following Growth Hormone Therapy |
| NCT04615273 foresiGHt results posted | TCH-306 2020-000929-42 | Ph 3 | completed | A Trial to Compare the Efficacy and Safety of Once-weekly Lonapegsomatropin With Placebo and a Daily Somatropin Product in Adults With Growth Hormone Deficiency |
| NCT01529944 | GHNOO-3680 2008-004535-38 | Ph 3 | completed | Genetic Testing of Noonan Subjects Previously Treated With Norditropin®. An Extension to Trial GHNOO-1658 |
| NCT03123913 STARFISH results posted | 1R01NS095813-01 | Ph 1 | completed | Study of Testosterone and rHGH in FSHD |
| NCT03038594 | 19-0298 / 15-0192 W81XWH-15-1-0143 | Ph 2, Ph 3 | completed | Growth Hormone Therapy for Muscle Regeneration in Severely Burned Patients |
| NCT02597660 | HUM00107019 | Ph 2 | withdrawn | A Study to Evaluate the Efficacy of Somatropin in the Treatment of Patellar Tendinopathy |
| NCT02092077 | TV1106-IMM-20001 2013-004468-69 | Ph 2 | terminated | A Phase 2, Safety and Dose-Finding Study in Treatment-Naive, Pre-Pubertal, Growth Hormone-Deficient Children |
| NCT01973244 | NN8640-4042 2013-000013-20, U1111-1138-2206 | Ph 1 | completed | A Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of Long-acting Growth Hormone (Somapacitan) Compared to Daily Dosing of Norditropin® SimpleXx® in Children With Growth Hormone Deficiency |
| NCT02229851 REAL 1 results posted | NN8640-4054 2013-002892-16, U1111-1145-0211 | Ph 3 | completed | Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency. |
| NCT01927861 results posted | GHLIQUID-4020 U1111-1131-5892, JapicCTI-132336 | Ph 3 | completed | Investigating the Long-term Efficacy and Safety of Two Doses of NN-220 (Somatropin) in Short Stature Due to Noonan Syndrome |
| NCT02382939 REAL 2 results posted | NN8640-4043 2014-000290-39, U1111-1152-3664 | Ph 3 | completed | A Trial to Compare the Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® FlexPro® for 26 Weeks in Previously Human Growth Hormone Treated Adults With Growth Hormone Deficiency |
| NCT04085224 | LG-HGCL010 | Ph 1 | completed | 6x3 Crossover, Bioavailability, Safety and Tolerability Among Different Eutropin Formulations in Healthy Volunteers |
| NCT01298960 FUNDEX001 | FUNDEX001 2010-022151-32 | Ph 2 | terminated | Growth Hormone (GH) in in Vitro Fertilization (IVF) Poor-responder Patients |
| NCT01592500 results posted | CP-4-004 2011-004553-60 | Ph 2 | completed | Safety and Efficacy Phase 2 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children |
| NCT02420353 results posted | HUM00087702 IND Exemption 123189 | Ph 2 | completed | Evaluation of rGH Therapy to Prevent Muscle Atrophy in Patients With ACL Tears |
| NCT02311894 results posted | ML29543 | Ph 4 | completed | A Post-Marketing Study of the Immunogenicity of Somatropin (Ribosomal Deoxyribo Nucleic Acid [rDNA] Origin) Injection (Nutropin AQ®) in Children With Growth Hormone Deficiency |
| NCT03015909 | LG-HGCL008 | Ph 4 | completed | Evaluation of the Ease of Use, Preference, and Safety of EutropinPen Inj. |
| NCT01778023 results posted | GH-3899 U1111-1125-4790, 2015-002613-30 | Ph 3 | completed | Efficacy and Safety of Recombinant Human Growth Hormone on Height Velocity in Subjects With Idiopathic Short Stature |
| NCT01401244 | GH-3939 U1111-1121-3640 | Ph 1 | completed | Bioequivalence of Two Somatropin Products (Norditropin® Versus Genotropin®) in Healthy Adult Volunteers |
| NCT00936403 | NN8630-1824 2008-008240-25 | Ph 2 | completed | A Single Dose Trial in Growth Hormone Deficient Children Investigating Safety, Pharmacokinetics and Pharmacodynamics of Long Acting Growth Hormone |
| NCT00943995 | 907-M02R | Ph 3 | completed | Three Times Weekly (TIW) Growth Hormone Therapy in Children on Hemodialysis |
| NCT01512095 | GH-3958 2012-003381-40, U1111-1122-9661 | Ph 1 | withdrawn | Bioequivalence of Two Products (Norditropin® Versus Nutropin AQ®) in Healthy Adult Volunteers |
| NCT00630487 IGHD results posted | A6281282 | Ph 3 | terminated | Efficacy of Somatropin in Adult Patients With Isolated Growth Hormone Deficiency |
| NCT01440686 HL-032 | HGR10I_1 | Ph 1 | completed | Safety, Pharmacokinetics and Pharmacodynamics Study of HL-032 in Healthy Male Volunteers |
| NCT00625872 SGA-POWER results posted | A6281283 | Ph 3 | terminated | Neuromuscular Changes In Small For Gestational Age Children During Somatropin Therapy |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
NORDITROPIN FLEXPRO FDA Label Details
Indications & Usage
FDA Label (PDF)NORDITROPIN FLEXPRO is indicated for the treatment of Growth Hormone Deficiency; Short Stature; Noonan Syndrome; Turner Syndrome; Small for Gestational Age; Prader-Willi Syndrome.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.