Somatrogon

Somatrogon-ghla binds to the GH receptor and initiates a signal transduction cascade culminating in changes in growth and metabolism. Somatrogon-ghla binding leads to activation of the STAT5b signaling pathway and increases the serum concentration of Insulin-like Growth Factor (IGF-1).

• 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. NGENLA is a human growth hormone analog indicated for treatment of pediatric patients aged 3 years and older who have growth failure due to inadequate secretion of endogenous growth hormone ( 1 ).

• • Acute critical illness after open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure due to the risk of increased mortality with somatropin [see Warnings and Precautions (5.1) ] . • Hypersensitivity to somatrogon-ghla or any of the excipients in NGENLA [see Warnings and Precautions (5.2) ].contraindicated

• NGENLA treatment should be supervised by a healthcare provider who is experienced in the diagnosis and management of pediatric patients with growth hormone deficiency ( 2.1 ). • Administer NGENLA by subcutaneous injection once weekly, on the same day each week, at any time of the day in the abdomen, thighs, buttocks, or upper arms with weekly rotation of injection site ( 2.1 ). • The recommended dosage is 0.66 mg/kg based on actual body weight administered once weekly ( 2.3 ). • Individualize dosage for each patient based on the growth response ( 2.3 ). • Patients switching from daily growth hormone may initiate treatment with once-weekly NGENLA on the day following their last daily injection ( 2.3 ). • If more than one injection is required to deliver a complete dose, each injection should be administered at a different injection site ( 2.3 ). 2.1 Important Dosing and Administration Information • NGENLA treatment should be supervised by a healthcare provider who is experienced in the diagnosis and management of pediatric patients aged 3 years and older with growth failure due to growth hormone deficiency (GHD) [see Indications and Usage (1) ] . • Refer patient to the Instructions for Use for complete administration instructions. • Administer NGENLA by subcutaneous injection, once weekly, on the same day each week, at any time of the day in the abdomen, thighs, buttocks, or upper arms. Rotate the injection site weekly.

• Severe Hypersensitivity : Severe hypersensitivity reactions may occur. In the event of an allergic reaction, seek prompt medical attention ( 5.2 ). • Increased Risk of Neoplasms : Monitor patients with preexisting tumors for progression or recurrence. Increased risk of a second neoplasm in childhood cancer survivors treated with somatropin – in particular meningiomas in patients treated with radiation to the head for their first neoplasm ( 5.3 ). • Glucose Intolerance and Diabetes Mellitus : NGENLA may decrease insulin sensitivity, particularly at higher doses. Monitor glucose levels periodically in all patients receiving NGENLA, especially in patients with existing diabetes mellitus or at risk for its development ( 5.4 ). • Intracranial Hypertension : Perform fundoscopic examinations prior to initiation of treatment with NGENLA and periodically thereafter. If preexisting papilledema is identified, evaluate the etiology and treat the underlying cause before initiating. If papilledema occurs with NGENLA, stop treatment ( 5.5 ). • Fluid Retention: May occur and may be dose dependent. Reduce dose as necessary ( 5.6 ). • Hypoadrenalism: Monitor patients for reduced serum cortisol levels and/or need for glucocorticoid dose increases in those with known hypoadrenalism ( 5.7 ). • Hypothyroidism : Monitor thyroid function periodically as hypothyroidism may become evident or worsen after initiation with NGENLA ( 5.8 ). • Slipped Capital Femoral Epiphysis : May develop. Evaluate patients with the onset of a limp or persistent hip or knee pain ( 5.9 ).

The following clinically significant adverse reactions are described elsewhere in the labeling: • Increased mortality in patients with acute critical illness [see Warnings and Precautions (5.1) ] • Severe hypersensitivity [see Warnings and Precautions (5.2) ] • Increased risk of neoplasm [see Warnings and Precautions (5.3) ] • Glucose intolerance and diabetes mellitus [see Warnings and Precautions (5.4) ] • Intracranial hypertension [see Warnings and Precautions (5.5) ] • Fluid retention [see Warnings and Precautions (5.6) ] • Hypoadrenalism [see Warnings and Precautions (5.7) ] • Hypothyroidism [see Warnings and Precautions (5.8) ] • Slipped capital femoral epiphysis [see Warnings and Precautions (5.9) ] • Progression of preexisting scoliosis [see Warnings and Precautions (5.10) ] • Pancreatitis [see Warnings and Precautions (5.11) ] • Lipoatrophy [see Warnings and Precautions (5.12) ] • Sudden death in pediatric patients with Prader-Willi syndrome [ see Warnings and Precautions (5.13) ] 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 ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

8.1 Pregnancy Risk Summary There are no available data on NGENLA use in pregnant women to evaluate for a drug associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In reproduction studies with pregnant rats, there was no evidence of embryo-fetal toxicity following administration of somatrogon-ghla subcutaneously during organogenesis at doses up to 45 times the maximum recommended human dose based on exposure (see Data ) . The background risk of major birth defects and miscarriage in the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In an embryo-fetal development toxicity study in rats, no adverse maternal or embryo-fetal effects were observed when somatrogon-ghla was administered via subcutaneous injection every 2 days from gestation day (GD) 6 to 18 at doses up to 30 mg/kg (45 times the maximum recommended human dose based on C av exposure). In a pre- and postnatal development study in rats, somatrogon-ghla was administered via subcutaneous injection to pregnant rats every 2 days from GD 6 to lactation day 20 at doses up to 30 mg/kg. There was no evidence of maternal toxicity and no adverse effects on the first generation (F1) offspring.

Metabolism

Somatrogon-ghla pharmacokinetics (PK) was assessed using a population PK approach for NGENLA in 151 pediatric patients (aged 3 to 15.5 years) with GHD. Absorption Following subcutaneous injection, serum concentrations increased slowly, peaking 6 to 25 hours with a median of 11 hours after dosing.

Acute overdosage may lead initially to hypoglycemia and subsequently to hyperglycemia. Overdose with growth hormone may cause fluid retention. Long-term overdosage could result in signs and symptoms of gigantism consistent with the effects of excess growth hormone.

• Jun 27, 2023BLABLA761184Pfizer Ireland Pharmaceuticals

1. 1Injection Site Pain77866%
2. 2Wrong Technique In Device Usage Process474.0%
3. 3Incorrect Dose Administered By Device463.9%
4. 4Injection Site Erythema453.8%
5. 5Injection Site Swelling393.3%
6. 6Headache342.9%
7. 7Device Mechanical Issue332.8%
8. 8Drug Dose Omission By Device322.7%
9. 9Needle Issue322.7%
10. 10Off Label Use322.7%
11. 11Patient-device Incompatibility302.6%
12. 12Device Delivery System Issue272.3%
13. 13Injection Site Mass262.2%
14. 14Device Leakage242.0%
15. 15Incorrect Dose Administered242.0%

The 9 most recently updated of 9 ClinicalTrials.gov registrations naming Somatrogon as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Study to Learn About Somatrogon in Patients With Pediatric Growth Hormone Deficiency (p GHD) in India.
  Recruiting · Observational · 50 enrolled · Pfizer
  NCT06587035updated 2026-06-05
• Evaluation of (Cardio)Metabolic and Auxological Outcomes of GHD Patients Under rhGH or LAGH With Stratification According to IGF-1 Levels
  Not yet recruiting · Interventional · 300 enrolled · Cliniques universitaires Saint-Luc- Université Catholique de Louvain
  NCT07173036updated 2026-05-11
• Comparison of Weekly Somatrogon to Daily Genotropin in Children Born Small for Gestational Age or With Idiopathic Short Stature.
  Recruiting · Phase 3 · Interventional · 254 enrolled · Rabin Medical Center
  NCT07226089updated 2026-04-30
• Korean Post-marketing Surveillance Ngenla® Pre-filled Pen Injection for the Treatment of Pediatric Patients With Growth Disturbance Due to Insufficient Secretion of Growth Hormone
  Active not recruiting · Observational · 565 enrolled · Pfizer
  NCT05509894updated 2026-01-27
• Ngenla Subcutaneous Injection Special Investigation
  Active not recruiting · Observational · 1 enrolled · Pfizer
  NCT05602766updated 2025-10-02
• Safety and Efficacy Phase 3 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children
  Completed · Phase 3 · Interventional · 224 enrolled · OPKO Health, Inc.
  NCT02968004updated 2025-07-20
• Patient Perception of Treatment Burden in Weekly Versus Daily Growth Hormone Injections in Children With GHD
  Completed · Phase 3 · Interventional · 87 enrolled · Pfizer
  NCT03831880updated 2021-10-14
• Safety and Efficacy Study of MOD-4023 to Treat Children With Growth Hormone Deficiency
  Completed · Phase 3 · Interventional · 44 enrolled · OPKO Health, Inc.
  NCT03874013updated 2021-08-12
• A Clinical Study Investigating the Comparability of Somatrogon in Two Different Drug Product Presentations
  Completed · Phase 1 · Interventional · 49 enrolled · OPKO Health, Inc.
  NCT03810664updated 2020-04-28

Frequently asked questions

How does Somatrogon work?

Somatrogon-ghla binds to the GH receptor and initiates a signal transduction cascade culminating in changes in growth and metabolism. Somatrogon-ghla binding leads to activation of the STAT5b signaling pathway and increases the serum concentration of Insulin-like Growth Factor (IGF-1).

What is Somatrogon used for?

According to FDA labeling, Somatrogon carries indications including: 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. NGENLA is a human growth hormone analog indicated for treatment of pediatric patients aged 3 years and older who have growth failure due to inadequate secretion of endogenous growth hormone ( 1 ).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Somatrogon?

Somatrogon is classified as Somatropin and somatropin agonists, Growth Hormone Secretagogue Receptor Agonists, Increased Growth Hormone Secretion.

What are the brand names for Somatrogon?

Somatrogon is marketed under brand names including Ngenla.

What are the contraindications for Somatrogon?

Somatrogon labeling lists contraindications including: • Acute critical illness after open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure due to the risk of increased mortality with somatropin [see Warnings and Precautions (5.1) ] . • Hypersensitivity to somatrogon-ghla or any of the excipients in NGENLA [see Warnings and Precautions (5.2) ].. Always consult the full prescribing information and a clinician.