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

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,...

Pharmacovigilance

Pharmacovigilance

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...

Drug Administration and Therapy Phases: Overview

Drug Administration and Therapy Phases: Overview

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...

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...

Bioequivalence studies: Biowaivers

Bioequivalence studies: Biowaivers

Body:In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...

Drug Regulation

Drug Regulation

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...

You might also read

Related Articles

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

Sort by

Same author

Tradipitant: First Approval.

Drugs·2026

Same author

Depemokimab: First Approval.

Drugs·2026

Same author

Sibeprenlimab: First Approval.

Drugs·2026

Same author

Zongertinib: First Approval.

Drugs·2026

Same author

Rilzabrutinib: First Approval.

Drugs·2025

Same author

Dorocubicel: First Approval.

Molecular diagnosis & therapy·2025

Same journal

Ecnoglutide: First Approvals.

Drugs·2026

Same journal

The Long Road to Long-Acting: What Oral PrEP and CAB-LA Teach Us About Scaling Lenacapavir.

Drugs·2026

Same journal

Botulinum Toxin Type A for Trigeminal and Postherpetic Neuralgia: An Umbrella Review of Systematic Reviews.

Drugs·2026

Same journal

Biologics and Small Molecule Inhibitors: Novel Therapeutic Strategies for Cutaneous Adverse Drug Reactions.

Drugs·2026

Same journal

Use of Sedative-Hypnotic Drugs and the Risk of Developing Alzheimer's Disease: A Systematic Review, Meta-Analysis and Meta-Regression.

Drugs·2026

Same journal

Relacorilant: First Approval.

Drugs·2026

See all related articles

Search research articles

Related Experiment Video

Updated: Oct 12, 2025

Optimized LC-MS/MS Method for the High-throughput Analysis of Clinical Samples of Ivacaftor, Its Major Metabolites, and Lumacaftor in Biological Fluids of Cystic Fibrosis Patients

Optimized LC-MS/MS Method for the High-throughput Analysis of Clinical Samples of Ivacaftor, Its Major Metabolites, and Lumacaftor in Biological Fluids of Cystic Fibrosis Patients

Published on: October 15, 2017

Avacopan: First Approval.

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

|November 26, 2021

Summary

This summary is machine-generated.

Avacopan, a C5aR antagonist, shows promise for treating ANCA-associated vasculitis. This article reviews its development milestones and recent regulatory approvals in Japan and the USA.

More Related Videos

Initial Evaluation of Antibody-conjugates Modified with Viral-derived Peptides for Increasing Cellular Accumulation and Improving Tumor Targeting

Initial Evaluation of Antibody-conjugates Modified with Viral-derived Peptides for Increasing Cellular Accumulation and Improving Tumor Targeting

Published on: March 8, 2018

Subconjunctival Administration of Adeno-associated Virus Vectors in Small Animal Models

Subconjunctival Administration of Adeno-associated Virus Vectors in Small Animal Models

Published on: March 16, 2022

Related Experiment Videos

Last Updated: Oct 12, 2025

Optimized LC-MS/MS Method for the High-throughput Analysis of Clinical Samples of Ivacaftor, Its Major Metabolites, and Lumacaftor in Biological Fluids of Cystic Fibrosis Patients

Optimized LC-MS/MS Method for the High-throughput Analysis of Clinical Samples of Ivacaftor, Its Major Metabolites, and Lumacaftor in Biological Fluids of Cystic Fibrosis Patients

Published on: October 15, 2017

Initial Evaluation of Antibody-conjugates Modified with Viral-derived Peptides for Increasing Cellular Accumulation and Improving Tumor Targeting

Initial Evaluation of Antibody-conjugates Modified with Viral-derived Peptides for Increasing Cellular Accumulation and Improving Tumor Targeting

Published on: March 8, 2018

Subconjunctival Administration of Adeno-associated Virus Vectors in Small Animal Models

Subconjunctival Administration of Adeno-associated Virus Vectors in Small Animal Models

Published on: March 16, 2022

Area of Science:

Pharmacology
Immunology
Nephrology

Background:

Avacopan is a novel complement 5a receptor (C5aR) antagonist developed for autoimmune diseases.
Its mechanism involves inhibiting C5aR activity on neutrophils, crucial in ANCA-associated vasculitis pathogenesis.
The precise therapeutic mechanism in ANCA-associated vasculitis remains under investigation.

Purpose of the Study:

To summarize the key development milestones of avacopan.
To highlight the recent regulatory approvals of avacopan in Japan and the USA.
To provide an overview of avacopan's therapeutic potential in autoimmune conditions.

Main Methods:

Review of avacopan's preclinical and clinical development.
Analysis of regulatory submission data for Japan and USA approvals.
Summary of ongoing investigations in other complement-mediated diseases.

Main Results:

Avacopan received its first approval in Japan in September 2021 for microscopic polyangiitis (MPA) and granulomatosis with polyangiitis (GPA).
US FDA approval was granted in October 2021 as an adjunctive treatment for severe active ANCA-associated vasculitis (MPA and GPA).
Positive opinion received in the EU, with ongoing reviews in Switzerland and Canada.

Conclusions:

Avacopan represents a significant advancement in the treatment of ANCA-associated vasculitis.
The drug's development journey highlights successful regulatory navigation and therapeutic potential.
Further research is exploring avacopan's efficacy in other complement-related disorders.