Related Concept Videos
01:24Drugs for Treatment of Crohn's Disease in IBD Using Biologic Agents: Anti-TNF
Tumor Necrosis Factor (TNF), a proinflammatory cytokine, contributes significantly to the inflammation seen in Crohn's disease. It exists as soluble TNF and membrane-bound TNF, with actions mediated through TNF receptors (TNFR). TNFR activation leads to the release of proinflammatory cytokines, T-cell activation, collagen production, and leukocyte migration, all contributing to inflammation in Crohn's disease. Anti-TNF monoclonal antibodies, namely infliximab (Remicade), adalimumab (Humira),...
01:29Drugs for Treatment of Crohn's Disease in IBD Using Immunomodulatory Agents
Crohn's disease is an inflammatory bowel disorder marked by chronic inflammation of the GI tract. Various treatment strategies for Crohn's disease are employed, such as immunomodulatory agents, glucocorticoids, and biologics or anti-TNF therapy. Azathioprine (Imuran), a commonly used immunomodulatory drug for Crohn's disease, is converted in the body to mercaptopurine, which inhibits purine biosynthesis and cell proliferation. Both are utilized in severe cases of Inflammatory Bowel Disease...
01:27Tumor Immunotherapy
Immunotherapy is a treatment that boosts or manipulates the immune system to fight diseases, including cancer. For instance, by stimulating an immune response through vaccinations against viruses that cause cancers, like hepatitis B virus and human papillomavirus, these diseases can be prevented. Nonetheless, some cancer cells can avoid the immune system due to their rapid mutation and division. The immune response to many cancers involves three phases: elimination, equilibrium, and escape.
01:29Drugs for Treatment of Ulcerative Colitis in IBD
Ulcerative colitis is a chronic inflammatory condition primarily affecting the colon and rectum. The primary drugs used in the treatment of ulcerative colitis are aminosalicylates. They exhibit anti-inflammatory and immunosuppressive properties. They modulate inflammatory mediators and inhibit the activity of nuclear factor κB (NF-κB). Aminosalicylates also reduce inflammation by inhibiting prostaglandin and leukotriene production and decreasing neutrophil chemotaxis and superoxide generation.
01:26FDA 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,...
01:28Drug Products: Biologics, Biosimilars and Interchangeables
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...
You might also read
Related Articles
Articles linked to this work by shared authors, journal, and citation graph.
Sort by
Same author
Subgroup Analysis of Pooled Phase 3 Efficacy Data from Two Randomized Trials of Gepotidacin Versus Nitrofurantoin in Uncomplicated Urinary Tract Infections (EAGLE-2 and EAGLE-3) including Participants with Uropathogens Not-Susceptible to Nitrofurantoin.
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America·2026
Same author
Early Symptom Response in Patients With Uncomplicated Urinary Tract Infection Treated With Gepotidacin or Nitrofurantoin: Pooled Analysis From Two Pivotal Phase 3 Studies.
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America·2026
Same author
Impact of updated regulatory guidelines on study results in contemporary uncomplicated urinary tract infection clinical trials and implications for trial conduct and drug development: a comparative analysis with EAGLE-2 and EAGLE-3.
Contemporary clinical trials communications·2025
Related Experiment Video
Updated: Jun 1, 2026
07:04
Identifying PD-1/PD-L1 Inhibitors with Surface Plasmon Resonance Technology
Published on: May 2, 2025
Ipilimumab: first global approval.
Fiona Cameron1, Glenn Whiteside, Caroline Perry
1RD Insight, Wolters Kluwer Pharma Solutions, Auckland, New Zealand.
Drugs
|June 15, 2011
Summary
Ipilimumab, an anti-CTLA-4 antibody, enhances T-cell responses against tumors. This immunotherapy has gained approval for melanoma and is under investigation for prostate and lung cancers.
Area of Science:
- Immunology
- Oncology
- Pharmacology
Background:
- Ipilimumab is a monoclonal antibody targeting cytotoxic T-lymphocyte antigen (CTLA)-4.
- CTLA-4 acts as a negative regulator of T-cell activity.
- Blocking CTLA-4 may enhance anti-tumor immune responses.
Purpose of the Study:
- To summarize the development milestones of intravenous ipilimumab.
- To highlight its approval for malignant melanoma treatment.
- To provide an overview of its ongoing clinical development in other cancers.
Main Methods:
- Review of preclinical studies on CTLA-4 blockade.
- Summary of clinical trial progress (Phase II and III).
- Information extracted from R&D Insight drug pipeline database.
Main Results:
- Ipilimumab approved in the US for first- or second-line melanoma treatment.
- Awaiting EU approval for second-line melanoma therapy.
- Investigational use in prostate and non-small cell lung cancer ongoing.
Conclusions:
- Ipilimumab represents a significant advancement in cancer immunotherapy.
- Its mechanism involves augmenting T-cell responses via CTLA-4 blockade.
- Further development is underway for broader oncological applications.