Search research articles

ABOUT JoVE

Overview Leadership Blog JoVE Help Center

AUTHORS

Publishing Process Editorial Board Scope & Policies Peer Review FAQ Submit

LIBRARIANS

Testimonials Subscriptions Access Resources Library Advisory Board FAQ

RESEARCH

JoVE Journal Methods Collections JoVE Encyclopedia of Experiments Archive

EDUCATION

JoVE Core JoVE Business JoVE Science Education JoVE Lab Manual Faculty Resource Center Faculty Site

Terms & Conditions of Use

Related Concept Videos

Pharmacokinetics in Pediatric Patients: Overview and Drug Absorption

Pharmacokinetics in Pediatric Patients: Overview and Drug Absorption

Understanding the physiological differences in the pediatric population is crucial for effective pharmacotherapy. Neonates, infants, and children exhibit significant variations in gastric pH, gastric emptying time, intestinal transit time, and biliary function. These variations profoundly affect oral drug absorption, necessitating a nuanced approach to pediatric dosing.Neonates present with a unique physiological profile, having a gastric pH greater than 4 and faster and more irregular gastric...

Pharmacokinetics in Pediatric Patients: Drug Metabolism

Pharmacokinetics in Pediatric Patients: Drug Metabolism

In pediatric care, understanding the nuances of hepatic drug metabolism is crucial, as it significantly differs from that of adults. This divergence is primarily due to the developmental stage of drug-metabolizing enzymes, which affects how medications are processed in the body. In neonates, for instance, the activity of Phase I enzymes—critical for the initial breakdown of drugs—is markedly reduced, functioning at just 20–40% of the levels seen in adults. This reduction poses...

Pharmacokinetics in Pediatric Patients: Drug Distribution

Pharmacokinetics in Pediatric Patients: Drug Distribution

Drug distribution in the pediatric population exhibits unique challenges and considerations due to the physiological differences between children, particularly neonates and infants, and adults. A crucial aspect of pediatric pharmacology is understanding how these differences impact the pharmacokinetics of various drugs, necessitating age-specific dosing strategies to ensure efficacy and safety.Neonates and infants have a higher total body water content, ~75%–90% of their body weight,...

Pharmacokinetics in Pediatric Patients: Drug Excretion

Pharmacokinetics in Pediatric Patients: Drug Excretion

In pediatric medicine, understanding the renal function and drug elimination nuances is crucial for administering safe and effective treatments. Newborns, in particular, display markedly slower renal functions than adults, profoundly affecting how drugs are cleared from their bodies. This slower drug clearance requires clinicians to extend the dosing intervals for many medications to prevent drug accumulation and toxicity while ensuring therapeutic efficacy.One key area where these adjustments...

Prescription, Nonprescription and Orphan Drugs

Prescription, Nonprescription and Orphan Drugs

Prescription drugs require a prescription from a medical practitioner and can only be obtained from a pharmacy. They have many applications, including treating pain, anxiety, and hypertension.
The misuse and addiction to prescription drugs is a growing problem that can affect people of all age groups, specifically teenagers. This can happen when prescription medications are used in ways not intended by the prescriber, such as taking someone else's prescription or using medication for...

FDA Approved Drugs: Changes to Approved Drugs

FDA Approved Drugs: Changes to Approved Drugs

Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by

Same author

Sepiapterin: First Approval.

Drugs·2025

Same author

Tiratricol: First Approval.

Drugs·2025

Same author

Recaticimab: First Approval.

Drugs·2025

Same author

Tasurgratinib Succinate: First Approval.

Drugs·2025

Same author

Correction: Fulzerasib: First Approval.

Drugs·2025

Same author

Marstacimab: First Approval.

Drugs·2024

Search research articles

Related Experiment Video

Updated: Oct 15, 2025

Automated Preparation of [68Ga]Ga-3BP-3940 on a Synthesis Module for PET Imaging of the Tumor Microenvironment

Automated Preparation of [⁶⁸Ga]Ga-3BP-3940 on a Synthesis Module for PET Imaging of the Tumor Microenvironment

Published on: April 25, 2025

Lonapegsomatropin: Pediatric First Approval.

Yvette N Lamb¹

¹Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. pdd@adis.com.

Paediatric Drugs

|October 28, 2021

Summary

Lonapegsomatropin, a novel long-acting human growth hormone, is now approved for pediatric growth hormone deficiency. This once-weekly injection offers a convenient alternative to daily treatments.

Area of Science:

Endocrinology
Pharmacology

Background:

Growth hormone deficiency (GHD) affects pediatric patients, necessitating effective treatment.
Current treatments for GHD often involve daily injections, posing challenges for adherence.

Purpose of the Study:

To summarize the development milestones of lonapegsomatropin.
To highlight the first pediatric approval of lonapegsomatropin for GHD.

Main Methods:

Review of development history and clinical trial data.
Analysis of regulatory submission and approval process.

Main Results:

Lonapegsomatropin (lonapegsomatropin-tcgd; SKYTROFA®) is a long-acting prodrug of somatropin.
Received US FDA approval in August 2021 for pediatric GHD (age ≥ 1 year, weight ≥ 11.5 kg).

More Related Videos

Lentiviral Vector-mediated Gene Therapy of Hepatocytes Ex Vivo for Autologous Transplantation in Swine

Lentiviral Vector-mediated Gene Therapy of Hepatocytes Ex Vivo for Autologous Transplantation in Swine

Published on: November 4, 2018

A Protocol for Rapid Post-mortem Cell Culture of Diffuse Intrinsic Pontine Glioma DIPG

A Protocol for Rapid Post-mortem Cell Culture of Diffuse Intrinsic Pontine Glioma DIPG

Published on: March 7, 2017

Related Experiment Videos

Last Updated: Oct 15, 2025

Automated Preparation of [68Ga]Ga-3BP-3940 on a Synthesis Module for PET Imaging of the Tumor Microenvironment

Automated Preparation of [⁶⁸Ga]Ga-3BP-3940 on a Synthesis Module for PET Imaging of the Tumor Microenvironment

Published on: April 25, 2025

Lentiviral Vector-mediated Gene Therapy of Hepatocytes Ex Vivo for Autologous Transplantation in Swine

Lentiviral Vector-mediated Gene Therapy of Hepatocytes Ex Vivo for Autologous Transplantation in Swine

Published on: November 4, 2018

A Protocol for Rapid Post-mortem Cell Culture of Diffuse Intrinsic Pontine Glioma DIPG

A Protocol for Rapid Post-mortem Cell Culture of Diffuse Intrinsic Pontine Glioma DIPG

Published on: March 7, 2017

Conclusions:

Lonapegsomatropin provides a once-weekly subcutaneous injection for GHD treatment.
This long-acting formulation simplifies GHD management, improving patient compliance.