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lonapegsomatropin

Generic: lonapegsomatropin·Brand: Skytrofa

lonapegsomatropin: sourced relationships with 1 company · 3 clinical trials tracked · 1 FDA decision.

lonapegsomatropin evidence translation

What we can confirm

1 FDA record · 3 tracked trials

What it means

Source-backed records connect lonapegsomatropin to ASND; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could lonapegsomatropin → ASND affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence2 indications · 0 study sponsors

Study sponsors

No additional listed-company sponsor is linked.

Dated Pipeline Records (1)
CompanyDated record stage
Ascendis Pharma A/S (ASND)
Reported 2021-08-25 · Current development: unknownSource
Approved
Clinical Trial Registry Records (3)

New InsiGHTS: A Multicenter, Phase 2, Randomized, Open-label, Active-controlled, Parallel Group Clinical Trial to Investigate the Safety, Tolerability, and Efficacy of Different Dose Levels of Once-weekly Lonapegsomatropin Compared to Daily Somatropin in Prepubertal Individuals With Turner Syndrome

NCT05690386Registry updated 2026-05-13·Phase 2
Active, not recruiting

Primary endpoint: Annualized Height Velocity (AHV) (cm/year)

InterventionalRandomizedopen48 targetStarted 2023-02Completion 2027-1219 sites · United StatesAscendis Pharma Endocrinology Division A/S

A Multicenter, Open-Label, Extension Trial to Investigate Long Term Efficacy and Safety of Lonapegsomatropin in Adults With Growth Hormone Deficiency

NCT05171855Registry updated 2026-07-07·Phase 3
Completed

Primary endpoint: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAE Leading to Study Discontinuation

Interventionalopen220 enrolledStarted 2021-12Completion 2024-1250 sites · Armenia, Australia, Canada, France…Ascendis Pharma Endocrinology Division A/S

foresiGHt: A Multicenter, Randomized, Parallel-arm, Placebo-controlled (Double- Blind) and Active-controlled (Open-label) Trial to Compare the Efficacy and Safety of Once-weekly Lonapegsomatropin With Placebo and a Daily Somatropin Product in Adults With Growth Hormone Deficiency

NCT04615273Registry updated 2026-07-07·Phase 3
Completed

Primary endpoint: Change From Baseline in Trunk Percent Fat at Week 38

InterventionalRandomizeddouble264 enrolledStarted 2020-12Completion 2023-1250 sites · Armenia, Australia, Canada, Denmark…Ascendis Pharma Endocrinology Division A/S
FDA Decisions1 records
Approval1 INDICATIONS AND USAGE SKYTROFA (lonapegsomatropin-tcgd) is a human growth hormone indicated for the: Treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone (GH). Replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD). SKYTROFA is a human growth hormone indicated for: Pediatric Patients: Treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone (GH) ( 1 ). Adults: Replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD) ( 1 ).(ASND)FDA ↗
BLA761177Type 1 - New Molecular EntityOrphan DrugStandardOtherInjectable

Frequently asked questions

Which companies have sourced relationships with lonapegsomatropin?

lonapegsomatropin has dated SEC/FDA relationship records for Ascendis Pharma A/S.

How many clinical trials involve lonapegsomatropin?

BioSniper tracks 3 clinical trials involving lonapegsomatropin.

What is lonapegsomatropin's latest FDA decision?

The most recent tracked FDA decision for lonapegsomatropin is Approval for 1 INDICATIONS AND USAGE SKYTROFA (lonapegsomatropin-tcgd) is a human growth hormone indicated for the: Treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone (GH). Replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD). SKYTROFA is a human growth hormone indicated for: Pediatric Patients: Treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone (GH) ( 1 ). Adults: Replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD) ( 1 )., dated August 25, 2021.