Data updated: May 26, 2026
NORDITROPIN (somatropin)
Trial Activity: Declining 5 active trials
Endocrine
Approved 2000-06-20
Development Insights
Novo Nordisk A/S conducting 17 trials (41%)
37 indications explored (Broad Platform)
→ growth hormone deficiency (7 trials)
→ genetic disorder (5 trials)
→ growth hormone disorder (5 trials)
6
Indications
--
Phase 3 Trials
25
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2000-06-20
- Patent Cliff
- 2014
- Revenue
- $280M (Q4-2020)
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
NORDITROPIN Approval History
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
99 FDA actions from 2000 to 2025 · 5 indication expansions
Jan 2017 SUPPL
Mfg
Jun 2016 SUPPL
Mfg
Jan 2016 SUPPL
Mfg
May 2013 SUPPL
Mfg
Aug 2001 SUPPL
Mfg
What NORDITROPIN Treats
6 FDA approvalsOriginally approved for its first indication in 2000 . Covers 6 distinct patient populations.
- Other (6)
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Clinical Trial Registry
32 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 |
| NCT03288103 results posted | 2017-1956 | Ph 1, Ph 2 | completed | Growth Hormone Treatment in Patients With Aggrecan (ACAN) Deficiency |
| NCT04513171 | TB1805GH | Ph 2, Ph 3 | completed | Safety and Efficacy of Y-shape Pegylated Somatropin in Growth Hormone Deficiency Children |
| 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. |
| NCT03075644 results posted | NN8640-4244 U1111-1181-1618, JapicCTI-173534 | Ph 3 | completed | A Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 52 Weeks in Previously Human Growth Hormone Treated Japanese 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 |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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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 FDA Label Details
Pro Intelligence Preview
Deep insights for NORDITROPIN
Revenue Insights
- • Q4-2020: $280M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2014
- • Generic/biosimilar risk
Trial Analysis
- • 41 total trials
- • Stage: Declining
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment