TheraRadar
Data updated: May 26, 2026

SKYTROFA (lonapegsomatropin-tcgd)

Trial Activity: Expansion 1 active trials
Orphan Drug
Endocrine Approved 2021-08-25

SKYTROFA is indicated for the treatment of Growth Hormone Deficiency; Growth Failure.

Source: FDA Label • ASCENDIS PHARMA ENCOCRINOLOGY DIV A/S • Recombinant Human Growth Hormone
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How SKYTROFA Works

SKYTROFA functions by binding to the growth hormone receptor in the cell membrane of target cells, which triggers intracellular signal transduction. This interaction results in direct metabolic effects and indirect effects mediated by insulin-like growth factor-1 (IGF-1), including the stimulation of protein synthesis and lipolysis. In pediatric patients, the drug promotes skeletal growth by stimulating the differentiation and proliferation of chondrocytes within the growth plates of long bones.

Source: FDA Label

Development Insights

Ascendis Pharma Endocrinology Division A/S conducting 3 trials (100%)
5 indications explored (Moderate)
→ endocrine system diseases (2 trials)
→ hormone deficiency (2 trials)
→ turner syndrome (1 trials)
2
Indications
--
Phase 3 Trials
4
Years on Market

Details

Status
Prescription
First Approved
2021-08-25
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

ASCENDIS PHARMA ENCOCRINOLOGY DIV A/S
Active Ingredient: LONAPEGSOMATROPIN-TCGD

SKYTROFA Approval History

2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
36 FDA actions from 2021 to 2025 · 1 indication expansions
Jul 2025 SUPPL
Efficacy
FDA Letter Label
Jul 2025 SUPPL
Label · Labeling
FDA Letter Label
Oct 2022 SUPPL
Label · Labeling
FDA Letter Label

What SKYTROFA Treats

2 indications

SKYTROFA is approved for 2 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Growth Hormone Deficiency
  • Growth Failure
Source: FDA Label

SKYTROFA Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Direct competitors

1

Same target(s) AND same indication — head-to-head.

GENOTROPIN
PHARMACIA
1995 5 indic.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

NGENLA
Pfizer
2023 1 indic.
SOGROYA
Novo Nordisk
2020 2 indic.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to SKYTROFA

3 of 10

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

SOGROYA
SOMAPACITAN-BECO
2 shared
Novo Nordisk
Shared indications:
Growth Hormone DeficiencyGrowth Failure
GENOTROPIN
SOMATROPIN
1 shared
PHARMACIA
Shared indications:
Growth Hormone Deficiency
GENOTROPIN PRESERVATIVE FREE
SOMATROPIN
1 shared
PHARMACIA
Shared indications:
Growth Hormone Deficiency
View all 10 similar drugs Pro
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Clinical Trial Registry

3 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
NCT05171855 results posted TCH-306EXT Ph 3 completed A Trial to Investigate Long Term Efficacy and Safety of Lonapegsomatropin in Adults With Growth Hormone Deficiency
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
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

SKYTROFA FDA Label Details

Indications & Usage

FDA Label (PDF)

SKYTROFA is indicated for the treatment of Growth Hormone Deficiency; Growth Failure.

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Data Sources

FDA Approval: BLA761177 → Label: DailyMed → Trials: ClinicalTrials.gov →

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