Growth Hormone Disorder

Endocrinology
31
Pipeline Programs
1
Companies
37
Clinical Trials
6
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
8
0
3
0
10
10
Early DiscoveryClinical DevelopmentMarket

On Market (6)

Approved therapies currently available

Novo Nordisk
NORDITROPINApproved
somatropin
Novo Nordisk
Recombinant Human Growth Hormone [EPC]injection2000
Novo Nordisk
NORDITROPIN FLEXPROApproved
somatropin
Novo Nordisk
Recombinant Human Growth Hormone [EPC]injection2000
Novo Nordisk
NORDITROPIN NORDIFLEXApproved
somatropin
Novo Nordisk
Recombinant Human Growth Hormone [EPC]injection2000
U
SAIZENApproved
somatropin
Unknown Company
injection1996
U
SEROSTIMApproved
somatropin
Unknown Company
injection1996
U
SEROSTIM LQApproved
somatropin
Unknown Company
subcutaneous1996

Competitive Landscape

1 companies ranked by most advanced pipeline stage

Novo Nordisk
Novo NordiskBAGSVAERD DENMARK, Denmark
37 programs
8
3
10
4
Norditropin NordiFlex®Phase 41 trial
somatropinPhase 41 trial
somatropinPhase 41 trial
somatropinPhase 41 trial
somapacitanPhase 31 trial
+32 more programs
Active Trials
NCT02005198Completed98Est. Dec 2015
NCT01068639Withdrawn0Est. Apr 2010
NCT01500486Completed84Est. Mar 2009
+34 more trials

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
Novo NordiskNorditropin NordiFlex®
Novo Nordisksomatropin
Novo Nordisksomatropin
Novo Nordisksomatropin
Novo Nordisksomapacitan
Novo Nordisksomapacitan
Novo Nordisksomatropin
Novo Nordisksomatropin
Novo Nordisksomatropin
Novo Nordisksomatropin
Novo Nordisksomatropin
Novo Nordisksomatropin
Novo Nordisksomatropin
Novo Nordisksomatropin
Novo Nordisksomapacitan

Showing 15 of 37 trials with date data

Clinical Trials (37)

Total enrollment: 55,808 patients across 37 trials

NCT01245374Novo NordiskNorditropin NordiFlex®

Norditropin NordiFlex® Device Compared to the Device Previously Used by Patients or Parents

Start: Nov 2010Est. completion: Apr 2011103 patients
Phase 4Completed

Liquid Somatropin Formulation in Children With Growth Hormone Deficiency

Start: Mar 2003Est. completion: Mar 2004176 patients
Phase 4Completed

Cardiovascular Effects on Growth Hormone Therapy in Adults With Growth Hormone Deficiency

Start: May 2001Est. completion: Nov 20027 patients
Phase 4Terminated

Effect of Somatropin on Left Ventricular Mass in Growth Hormone Deficient Adult Patients

Start: Oct 1998Est. completion: Dec 200222 patients
Phase 4Completed

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

Start: Mar 2017Est. completion: Oct 201862 patients
Phase 3Completed

Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency.

Start: Oct 2014Est. completion: May 2018301 patients
Phase 3Completed

Long-term Trial on Growth Hormone Deficiency in Adults (GHDA)

Start: Nov 2004Est. completion: Sep 200686 patients
Phase 3Completed

Long-term Trial on Growth Hormone Deficiency in Adults (GHDA)

Start: Dec 2003Est. completion: Dec 2005112 patients
Phase 3Completed

Growth Hormone Deficiency in Adults (GHDA)

Start: May 2003Est. completion: Jan 2005121 patients
Phase 3Completed

Somatropin (Norditropin) in Insulin-like Growth Factor (IGF) Deficient Children

Start: May 2003Est. completion: Dec 2006149 patients
Phase 3Completed

Effect of Growth Hormone on Bone Mineral Density in Young Adults With Child-hood Onset Growth Hormone Deficiency

Start: Feb 2002Est. completion: Jul 2006161 patients
Phase 3Completed

Safety and Efficacy of Somatropin in Children With Growth Hormone Deficiency

Start: May 2001Est. completion: Mar 200378 patients
Phase 3Completed

Evaluating Acceptance of New Liquid Somatropin Formulation in Children With Growth Hormone Deficiency

Start: Oct 2000Est. completion: Oct 2002168 patients
Phase 3Completed

Effect of Growth Hormone in Children With Growth Hormone Deficiency

Start: Aug 2000Est. completion: May 2004173 patients
Phase 3Completed

Investigating Efficacy and Safety of Once-weekly NNC0195-0092 Treatment Compared to Daily Growth Hormone Treatment (Norditropin® FlexPro®) in Growth Hormone Treatment naïve Pre-pubertal Children With Growth Hormone Deficiency

Start: Mar 2016Est. completion: Sep 202476 patients
Phase 2Completed

A Single Dose Trial in Growth Hormone Deficient Children Investigating Safety, Pharmacokinetics and Pharmacodynamics of Long Acting Growth Hormone

Start: Aug 2009Est. completion: Jul 201031 patients
Phase 2Completed

Dose Study in Growth Hormone Deficient Adults Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC126-0083

Start: Jul 2008Est. completion: Mar 200933 patients
Phase 2Completed

Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Mild and Moderate Degrees of Hepatic Impairment Compared to Subjects With Normal Hepatic Function.

Start: Aug 2017Est. completion: Mar 201834 patients
Phase 1Completed

Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Various Degrees of Impaired Renal Function Compared to Subjects With Normal Renal Function

Start: Jun 2017Est. completion: May 201844 patients
Phase 1Completed

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

Start: Dec 2013Est. completion: Nov 201432 patients
Phase 1Completed

A Trial Investigating the Safety, Tolerability, Availability and Distribution in the Body of Once-weekly Long-acting Growth Hormone (Somapacitan) Compared to Once Daily Norditropin NordiFlex® in Adults With Growth Hormone Deficiency

Start: Oct 2012Est. completion: Nov 201335 patients
Phase 1Completed

First Human Dose Trial of NNC0195-0092 (Somapacitan) in Healthy Subjects

Start: Jan 2012Est. completion: Mar 2013105 patients
Phase 1Completed

Dose Study in Healthy Japanese Males Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC126-0083

Start: Jul 2008Est. completion: Apr 200940 patients
Phase 1Completed

Dose Study in Healthy Males Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC126-0083 Compared to Norditropin® SimpleXx®

Start: Aug 2007Est. completion: Jan 200856 patients
Phase 1Completed

A Single Dose Trial in Healthy Caucasians and Japanese Subjects Investigating the Pharmacokinetics of Somatropin

Start: Apr 2000Est. completion: Jun 200086 patients
Phase 1Completed
NCT02005198Novo NordiskNo treatment given

Assessing the Minimal Important Difference (MID) of the Treatment Related Impact Measure-Adult Growth Hormone Deficiency (TRIM-AGHD)

Start: Mar 2014Est. completion: Dec 201598 patients
N/ACompleted
NCT01327924Novo NordiskNorditropin NordiFlex®

Usability and Tolerability of the Norditropin NordiFlex® Injection Device in Children Never Previously Treated With Growth Hormone

Start: Apr 2011Est. completion: Jun 201277 patients
N/ACompleted
NCT01068639Novo NordiskNo treatment given

An Observational Study on Treatment Compliance by Children Treated With Growth Hormone

Start: Feb 2010Est. completion: Apr 20100
N/AWithdrawn

Observational Study of the Safety and Efficacy of Norditropin® in Adult Patients With Growth Hormone Deficiency

Start: Oct 2009Est. completion: Dec 2014387 patients
N/ACompleted

An Observational Study Validating a Score That Quantifies the Therapeutic Response to Treatment With Norditropin®

Start: Jul 2009Est. completion: Jun 2014121 patients
N/ACompleted
NCT01500486Novo NordiskNordiFlex PenMate™

Observational Study of Norditropin NordiFlex® With NordiFlex PenMate™

Start: Jan 2007Est. completion: Mar 200984 patients
N/ACompleted

Observational Prospective Study on Patients Treated With Norditropin®

Start: Apr 2006Est. completion: Dec 201621,249 patients
N/ACompleted

Non-interventional Study of Patients Using Norditropin® for Growth Hormone Deficiency or Turner Syndrome

Start: May 2005Est. completion: Jun 20152,016 patients
N/ACompleted

French National Registry of Adults With Growth Hormone Deficiency Treated With Somatropin

Start: Jul 2003Est. completion: Nov 2011331 patients
N/ACompleted

Safety and Efficacy of Long-term Somatropin Treatment in Adults

Start: Jul 2003Est. completion: Jun 2014752 patients
N/ACompleted

An Observational Study (Registry) Assessing Treatment Outcomes and Safety for Children and Adults Who Are Prescribed Norditropin® (Human Growth Hormone)

Start: Jun 2002Est. completion: Sep 201622,960 patients
N/ACompleted

Safety and Efficacy of Long-term Somatropin Treatment in Children

Start: Jan 2001Est. completion: Dec 20115,442 patients
N/ACompleted

Related Jobs in Endocrinology

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

10 late-stage (Phase 3) programs — potential near-term approvals
1 companies competing in this space