Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Concept Videos

FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

329
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,...
329
Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

352
Biologics, derived from living sources such as humans, animals, or microorganisms, represent a significant category of pharmaceuticals. These complex molecules, developed through advanced biotechnological methods or purified from natural sources, include essential medical treatments like insulin and growth hormones. The complexity of biologics arises from their large molecular structures and the intricate processes required for their production, making them distinct from conventional...
352
Prescription, Nonprescription and Orphan Drugs01:02

Prescription, Nonprescription and Orphan Drugs

1.4K
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...
1.4K
Drug Administration and Therapy Phases: Overview01:26

Drug Administration and Therapy Phases: Overview

1.7K
Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
1.7K
Pharmacovigilance01:19

Pharmacovigilance

2.0K
Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
2.0K
Drug Regulation01:25

Drug Regulation

3.3K
Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
3.3K

You might also read

Related Articles

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

Sort by
Same author

Selexipag: A Review in Pulmonary Arterial Hypertension.

American journal of cardiovascular drugs : drugs, devices, and other interventions·2016
Same author

Erratum to: Etanercept (SB4): A Review in Autoimmune Inflammatory Diseases.

BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy·2016
Same author

Trifluridine/Tipiracil: A Review in Metastatic Colorectal Cancer.

Drugs·2016
Same author

Etanercept (SB4): A Review in Autoimmune Inflammatory Diseases.

BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy·2016
Same author

Erratum to: Susoctocog Alfa: A Review in Acquired Haemophilia A.

Drugs·2016
Same author

Eltrombopag: A Review in Paediatric Chronic Immune Thrombocytopenia.

Drugs·2016

Related Experiment Video

Updated: Apr 4, 2026

A Rapid Screening Workflow to Identify Potential Combination Therapy for GBM using Patient-Derived Glioma Stem Cells
05:29

A Rapid Screening Workflow to Identify Potential Combination Therapy for GBM using Patient-Derived Glioma Stem Cells

Published on: March 28, 2021

3.3K

Sonidegib: First Global Approval.

Celeste B Burness1

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

Drugs
|September 2, 2015
PubMed
Summary

Sonidegib, a Smoothened (SMO) receptor antagonist, is approved for advanced basal cell carcinoma (BCC). This oral medication shows promise in treating various cancers by targeting the Hedgehog signaling pathway.

Area of Science:

  • Oncology
  • Pharmacology
  • Molecular Biology

Background:

  • The Hedgehog signaling pathway is crucial for tissue development and homeostasis.
  • Dysregulation of this pathway is implicated in various cancers, including basal cell carcinoma (BCC).
  • Sonidegib is an orally bioavailable small molecule antagonist targeting the Smoothened (SMO) receptor within this pathway.

Purpose of the Study:

  • To summarize the development milestones of sonidegib.
  • To highlight its regulatory approvals for advanced and locally advanced basal cell carcinoma (BCC).
  • To review ongoing investigations in other malignancies.

Main Methods:

  • Review of clinical development data for sonidegib.
  • Analysis of regulatory submission and approval timelines.

More Related Videos

A Pipeline to Investigate the Structures and Signaling Pathways of Sphingosine 1-Phosphate Receptors
12:27

A Pipeline to Investigate the Structures and Signaling Pathways of Sphingosine 1-Phosphate Receptors

Published on: June 8, 2022

4.1K
Intrathecal Delivery of Antisense Oligonucleotides in the Rat Central Nervous System
07:47

Intrathecal Delivery of Antisense Oligonucleotides in the Rat Central Nervous System

Published on: October 29, 2019

19.9K

Related Experiment Videos

Last Updated: Apr 4, 2026

A Rapid Screening Workflow to Identify Potential Combination Therapy for GBM using Patient-Derived Glioma Stem Cells
05:29

A Rapid Screening Workflow to Identify Potential Combination Therapy for GBM using Patient-Derived Glioma Stem Cells

Published on: March 28, 2021

3.3K
A Pipeline to Investigate the Structures and Signaling Pathways of Sphingosine 1-Phosphate Receptors
12:27

A Pipeline to Investigate the Structures and Signaling Pathways of Sphingosine 1-Phosphate Receptors

Published on: June 8, 2022

4.1K
Intrathecal Delivery of Antisense Oligonucleotides in the Rat Central Nervous System
07:47

Intrathecal Delivery of Antisense Oligonucleotides in the Rat Central Nervous System

Published on: October 29, 2019

19.9K
  • Summary of ongoing Phase I/II trials in diverse cancer types.

    • Main Results:

    • Sonidegib (Odomzo™) received approval in Switzerland for advanced BCC.
    • US and EU approvals were granted for locally advanced BCC in specific patient populations.
    • Clinical trials are underway for sonidegib in multiple myeloma, medulloblastoma, and other cancers.

    Conclusions:

    • Sonidegib represents a significant advancement in the treatment of advanced and locally advanced BCC.
    • Its development highlights the therapeutic potential of targeting the Hedgehog pathway in oncology.
    • Further research is ongoing to explore sonidegib's efficacy across a broader spectrum of malignancies.