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HomeAbout NGENLAEfficacy & SafetyEfficacy &
SafetyPhase 3 Main Study + SafetyPhase 3 OLE Study + SafetyPhase 2 Study + SafetyDosingDosingDosingAdministrationMyNgenla PlanIGF-1 MonitoringAccess & SupportAccess &
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Prescribing InformationIndication Patient Site
Once-weekly NGENLAUp to 8 years of clinical data1‑3Phase 3 Main Study + SafetyPhase 3 OLE Study + SafetyPhase 2 Study + SafetyPhase 2 safety and dose-finding study design2 Phase 2 randomized, open-label, dose-finding study comprised of 5 treatment periods up to 8 years. In the main study (Periods I and II), 53 prepubertal children with GHD were randomized to once-weekly NGENLA (0.25, 0.48, or 0.66 mg/kg/week) or once-daily GENOTROPIN (0.034 mg/kg/day); 48 continued into the OLE, consisting of Period III (original NGENLA dose, GENOTROPIN recipients randomized to one of three NGENLA doses), Period IV (NGENLA 0.66 mg/kg/week), and Period V (prefilled NGENLA pen [0.66 mg/kg/week]).2,3

End points2
Primary end point
  • Safety* 
Secondary end points
  • AHV 
  • Change in height SDS 
  • Change in IGF-1 SDS 
Inclusion criteria4
  • Prepubertal children aged ≥3 years and <11 years (girls), <12 years (boys) 
  • Isolated GHD or GHD due to multiple pituitary hormone deficiency (on stable replacement therapy for ≥3 months) 
  • Peak plasma GH level ≤10 ng/mL on 2 different provocative tests (insulin tolerance/arginine/clonidine/glucagon, with or without propranolol/L‑dopa plus propranolol) 
  • Bone age ≤ chronological age <10 years (girls), <11 years (boys) 
  • Impaired height (≥SD below the mean); impaired AHV SDS < -0.7 (≤25th percentile for chronological age) 
  • BMI within +2 SD of mean BMI 
  • Baseline IGF-1 SDS ≤ -1.0 
  • Normal karyotype for girls
  • No signs or symptoms of intracranial hypertension
AHV, annualized height velocity; BMI, body mass index; GH, growth hormone; GHD growth hormone deficiency; IGF‑1, insulin-like growth factor 1; SD, standard deviation; SDS, standard deviation score.All patients randomized to receive 1 of the 3 NGENLA doses started treatment for 2 weeks with the lowest NGENLA dose, which based on the patient's dose allocation, was followed by a dose increase to the next dose level every 2 weeks until the final allocated dose was reached.5Safety evaluations included vital signs, injection site reactions, immunogenic response, and laboratory safety assessments. The safety monitoring for most safety evaluations was initially done weekly and then monthly in the first 6 months, then every 3 months until end of study.2Phase 2 open-label extension (OLE) study design2

Phase 2 OLE study design2†
In extension year 1 (n=48), patients taking NGENLA continued their assigned dose. Patients taking GENOTROPIN® (somatropin) were re-randomized to 1 of the 3 NGENLA doses. A total of 14 patients continued on the FDA-approved 0.66 mg/kg/week dose from the main year. 
In extension years 2 and beyond, patients were transitioned to NGENLA 0.66 mg/kg/week.

End points2
Primary end point

  • Safety

Secondary end points

  • AHV
  • Change in height SDS 
  • Annual bone maturation
Key inclusion criteria2
Patients who completed 12 months of treatment in the safety and dose-finding portion of the main study. 

Study participants2
  • 48 of 53 patients who completed the main study were randomized and entered the OLE study 
  • At the start of year 1 of OLE, the majority (66.7%) of patients were male and almost all (93.8%) were White 
AHV, annualized height velocity; FDA, Food and Drug Administration; SDS, standard deviation score.The number of patients reflects the new patient numbers for each arm after GENOTROPIN re-randomization.2Most patients switched from the single-use vials to a multidose pen after the completion of extension year 3. Extension year 4 is the first year where patients were evaluated on the prefilled pen device.2Year 2, n=44; year 3, n=43; and year 4, n=38.2NGENLA has up to 8 years of height standard deviation score (SDS) data2,3,5
Study limitations
  • The primary objective of the phase 2 OLE was to evaluate safety of NGENLA. Any inference of clinical significance should be interpreted with caution as the study was open label and lacked a comparator arm. Statistical analyses of these data are descriptive, and no formal hypothesis testing was performed2* 
  • Results for efficacy outcomes were unable to be measured in year 5 as patients were switched from vial and syringe to the prefilled pen device on a rolling basis. Efficacy outcomes measurement resumes in year 6 with a complete patient population switched to the prefilled pen device3
Phase 2 randomized, open-label, dose-finding study comprised of 5 treatment periods up to 8 years. In the main study (Periods I and II), 53 prepubertal children with GHD were randomized to once-weekly NGENLA (0.25, 0.48, or 0.66 mg/kg/week) or once-daily GENOTROPIN (0.034 mg/kg/day); 48 continued into the OLE, consisting of Period III (original NGENLA dose, GENOTROPIN recipients randomized to one of three NGENLA doses), Period IV (NGENLA 0.66 mg/kg/week), and Period V (prefilled NGENLA pen [0.66 mg/kg/week]).4Phase 2 safety data3The safety profile of NGENLA was evaluated across 8 years in a phase 2 open-label extension

THE OVERALL INCIDENCE OF TEAEs IN PATIENTS DURING THE OLE3 TEAE, treatment-emergent adverse event.References:NGENLA. Prescribing information. Pfizer Inc.; 2025.Data on file. Pfizer Inc., New York, NY. Zadik Z, Zelinska N, Iotova V, et al. Long-term efficacy and safety of once-weekly somatrogon in pediatric subjects with growth hormone deficiency: results from up to 8 years of somatrogon treatment. Poster presented at: Annual Meeting of the Endocrine Society 2023; June 15-18, 2023.Zelinska N, Iotova V, Skorodok J, et al. Long-acting C-terminal peptide–modified hGH (MOD-4023): results of a safety and dose-finding study in GHD children. J Clin Endocrinol Metab. 2017;102(5):1578-1587. doi:10.1210/jc.2016-3547Zadik 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;36(3):261-269. doi:10.1515/jpem-2022-0359Access & Support

NGENLA has broad formulary coverage. Pfizer offers the NGENLA Copay Program and additional resources to help eligible patients starting on NGENLA

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PP-SMT-USA-0722
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INDICATIONNgenla is indicated for the treatment of pediatric patients aged 3 years and older who have growth failure due to an inadequate secretion of endogenous growth hormone.
IMPORTANT SAFETY INFORMATIONCONTRAINDICATIONS
Ngenla is contraindicated in patients with:
  • Acute critical illness after open heart surgery, abdominal surgery or multiple accidental trauma, or acute respiratory failure due to the risk of increased mortality with somatropin
  • Hypersensitivity to somatrogon-ghla or any of the excipients in Ngenla
  • Closed epiphyses
  • Active malignancy due to the risk of malignancy progression
  • Active proliferative or severe non-proliferative diabetic retinopathy
  • Prader-Willi syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea or have severe respiratory impairment due to the sudden risk of death
WARNINGS AND PRECAUTIONS
Increased Mortality in Patients with Acute Critical Illness: Increased mortality in patients with acute critical illness due to complications following open heart surgery, abdominal surgery, or multiple accidental trauma, or those with acute respiratory failure has been reported with somatropin.Severe Hypersensitivity: Severe systemic hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with somatropin. Inform patients and/or caregivers that such reactions are possible, and to seek prompt medical attention if allergic reaction occurs.Increased Risk of Neoplasms: There is an increased risk of malignancy progression with somatropin treatment in patients with active malignancy. Any preexisting malignancy should be inactive, and its treatment should be completed, prior to instituting therapy. In childhood cancer survivors treated with radiation to the brain/head for their first neoplasm and developed subsequent GHD and were treated with somatropin, an increased risk of a second neoplasm has been reported. Monitor patients with a history of GHD secondary to an intracranial neoplasm for progression or recurrence of the tumor. Children with certain rare genetic causes of short stature have an increased risk of developing malignancies. Monitor for development of neoplasms. Monitor patients for increased growth or potential malignant changes of preexisting nevi. Advise patients and/or caregivers to report marked changes in behavior, onset of headaches, vision disturbances, and/or changes in skin pigmentation or changes in the appearance of preexisting nevi. Glucose Intolerance and Diabetes Mellitus: Treatment with growth hormone may decrease insulin sensitivity, particularly at higher doses. New-onset type 2 diabetes mellitus has been reported. Patients with undiagnosed pre-diabetes and diabetes mellitus may experience worsened glycemic control and become symptomatic. Monitor glucose levels periodically in all patients receiving Ngenla, especially in those with risk factors for diabetes mellitus. The doses of antidiabetic agents may require adjustment when Ngenla is initiated. Intracranial Hypertension (IH): Has been reported in patients treated with somatropin, usually within 8 weeks of treatment initiation. Perform fundoscopic examination prior to initiation of treatment and periodically thereafter. If papilledema is identified, evaluate the etiology, and treat the underlying cause before initiating Ngenla. Temporarily discontinue Ngenla in patients with evidence of IH. If IH is confirmed, restart Ngenla at a lower dose after IH signs and symptoms have resolved. Fluid Retention: May occur during Ngenla therapy. Clinical manifestations of fluid retention are usually transient and dose dependent. Hypoadrenalism: Patients receiving growth hormone therapy who have or are at risk for pituitary hormone deficiencies may be at risk for reduced serum cortisol levels and/or unmasking of central (secondary) hypoadrenalism. Patients treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in their maintenance or stress doses following initiation of Ngenla. Monitor patients with known hypoadrenalism for reduced serum cortisol levels and/or need for glucocorticoid dose increases. Hypothyroidism: Undiagnosed/untreated hypothyroidism may prevent an optimal response to Ngenla. Central (secondary) hypothyroidism may first become evident or worsen during treatment with growth hormone therapy. Monitor thyroid function periodically and appropriately initiate or adjust thyroid hormone replacement therapy. Slipped Capital Femoral Epiphysis: Slipped capital femoral epiphysis may occur more frequently in patients undergoing rapid growth. Slipped capital femoral epiphysis may lead to osteonecrosis. Cases of slipped capital femoral epiphysis with or without osteonecrosis have been reported in pediatric patients with short stature receiving somatropin. Evaluate pediatric patients with the onset of a limp or complaints of persistent hip or knee pain for slipped capital femoral epiphysis and osteonecrosis and manage accordingly. Progression of Preexisting Scoliosis: Monitor patients with a history of scoliosis for disease progression. Pancreatitis: Cases of pancreatitis have been reported in patients receiving somatropin. The risk may be greater in pediatric patients compared with adults. Consider pancreatitis in patients who develop persistent severe abdominal pain. Lipoatrophy: May occur if Ngenla is administered at the same site over a long period of time. Rotate injection sites to reduce this risk. Sudden Death in Pediatric Patients with Prader-Willi Syndrome: There have been reports of sudden death after initiating therapy with somatropin in pediatric patients with Prader‑Willi syndrome who had one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnea, or unidentified respiratory infection. Male patients with one or more of these factors may be at greater risk. Ngenla is not indicated for the treatment of pediatric patients who have growth failure due to genetically confirmed Prader‑Willi syndrome. Laboratory Tests: Serum levels of phosphorus, alkaline phosphatase, and parathyroid hormone may increase with NGENLA therapy. Monitor as appropriate. ADVERSE REACTIONS
Adverse reactions reported in ≥5% of patients treated with Ngenla are injection site reactions, nasopharyngitis, headache, pyrexia, anemia, cough, vomiting, hypothyroidism, abdominal pain, rash, and oropharyngeal pain. Health care providers should supervise the first injection and provide appropriate training and instruction for the proper use of all NGENLA devices.DRUG INTERACTIONS
Glucocorticoids: Patients treated with glucocorticoid for hypoadrenalism may require an increase in their maintenance or stress doses.Cytochrome P450-Metabolized Drugs: Ngenla may alter the clearance. Monitor carefully.Oral Estrogen: Patients receiving oral estrogen replacement may require higher Ngenla dosages.Insulin and/or Other Antihyperglycemic Agents: Dose adjustment of insulin and/or antihyperglycemic agent may be required.
INDICATION
Ngenla is indicated for the treatment of pediatric patients aged 3 years and older who have growth failure due to an inadequate secretion of endogenous growth hormone.