This site is intended only for healthcare professionals resident in the Republic of Ireland




Sign in or RegisterLog out Our medicinesTherapy areasExplore contentExplore contentMaterialsVideosPodcastsLet’s connectLet's connectContact usSign up



AboutEfficacySafetyDosingSupport & ResourcesPatient SupportMaterialsVideos

▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. Refer to section 4.8 of the SmPC for how to report adverse reactions.

A once-weekly growth hormone (GH) with an efficacy profile comparable to daily GH in children and adolescents from age 3 years with GH deficiency1,2Based on a 1-year, phase 3, noninferiority study, the efficacy of NGENLA demonstrated comparable to daily GH at 1 year (N=224)1,2

Graph created based on the primary results of the NGENLA phase III study2

Phase 3 Study Design

Open-label, multicenter, randomized, active-controlled, study in prepubertal children with GH deficiency to assess efficacy and safety of NGENLA once weekly versus GENOTROPIN® (somatropin) for injection once daily after 12 months of treatment.1,2

IGF-1 SDS profiles over the dosing interval (1 week) during 12 months of treatment with NGENLA2** The above graph is based on the measurement of IGF-1 SDS profiles over time reported in the phase 3 study.

IGF-1, insulin-like growth factor 1; SDS, standard deviation score.

5 years of efficacy data from an open-label extension of a phase 2 study.1,3

NGENLA delivered sustained growth up to 5 years of long-term use in children with GH deficiency3

Key findings over 5 years:

  • Annual height velocity indicated a sustained growth response3
  • Progressive gains in mean height SDS were achieved3
Phase 2 Extension Study Design

Phase 2, open-label, randomized, dose-finding, and safety study with yearly extension in prepubertal patients with GH deficiency. Fifty-three patients were randomized and treated with one of 3 doses of once weekly somatrogon (0.25 mg/kg/week [n=13], 0.48 mg/kg/week [n=15], or 0.66 mg/kg/week [n=14]) or GENOTROPIN administered once daily (0.034 mg/kg/day [n= 11]). Patients who completed 12 months of active treatment in the main study period remained eligible for inclusion in the open-label extension study. The open-label extension followed patients on NGENLA for up to 5 additional years; in years 2 and beyond, all patients were transitioned to NGENLA at 0.66 mg/kg/week.3,4

GENOTROPIN is a registered trademark of Pfizer Inc.Consider NGENLA for all your appropriate patients age 3 years and older with pediatric GH deficiency1

Ngenla▼ Prescribing Information

Genotropin Prescribing Information

References:NGENLA® Summary of Product CharacteristicsDeal (2022). Efficacy and Safety of Weekly Somatrogon vs Daily Somatropin in Children With Growth Hormone Deficiency:A Phase 3 Study. JCEM, 2022, 107, e2717–e2728Zadik Z, Zelinska N, Iotova V et al. An open-label extension of a phase 2 dose-finding study of once-weekly somatrogon vs. once-daily Genotropin in children with short stature due to growth hormone deficiency: results following 5 years of treatment. J Pediatr Endocrinol Metab 2023; aopDATA ON FILE – REFSMT1150, PFIZER LTD: NGENLA® (somatrogon) CP-4-004 Open Label Extension Annual Height Velocity by year and treatment group.

Learn more about clinical safety data of NGENLA in children with GH deficiency.

View safety data

Click here for more information on NGENLA once weekly dosing and administration.

See instructions

Support for your patients throughout their treatment journey.

Explore more

Legal Category: S1A
Further information is available upon request

PP-NGE-IRL-0016 Date of Preparation Dec 2022

Adverse events should be reported. Report an adverse event to your national reporting system (HPRA Pharmacovigilance)

Adverse events should also be reported to Pfizer Medical Information on 1800 633 363

PfizerPro AccountPfizerPro Account

Please sign in or register to gain access to information relating to Pfizer medicines and vaccines, medical conditions, patient materials and services.

Sign in or RegisterRegisterAccountLog out

This site is intended only for healthcare professionals resident in the Republic of Ireland. If you are a member of the public wishing to access information on a specific medicine, please visit


This website is brought to you by Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, Ireland. Registered in the Republic of Ireland No. 127002.


Copyright © 2023 Pfizer Limited. All rights reserved.

PP-UNP-IRL-0176. January 2023
For Healthcare Professionals in the Republic of Ireland *

The information contained on this site is reserved exclusively for healthcare professionals resident in the Republic of Ireland.

I confirm that I am a healthcare professional resident in the Republic of Ireland.*

I accept and agree to the terms of use.*

If you select 'No', you will be redirected to, where you will be able to access information on Pfizer Healthcare Ireland.

PP-UNP-IRL-0176. January 2023

Yes No
You are now leaving PfizerPro
You are now leaving PfizerPro Ireland. Links to external websites are provided as a resource to the viewer. This website is neither owned nor controlled by Pfizer. Pfizer accepts no responsibility for the content or services of the linked site.