p53-MDM2 Interaction Inhibitors Market: Competitive Landscape, Pipeline, and Market Analysis 2023

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p53-MDM2 Interaction Inhibitors are a class of promising anticancer drugs designed to target the critical interaction between the tumor suppressor protein p53 and the oncogenic protein MDM2. The p53 pathway is pivotal in regulating cell growth and preventing tumor formation. However, in many cancer cases, the MDM2 protein inhibits p53's tumor-suppressing activity by promoting its degradation. Inhibitors of this interaction offer a potential therapeutic strategy to restore p53 function and trigger apoptosis in cancer cells, holding great promise in cancer treatment. p53-MDM2 Interaction Inhibitors target the p53 and MDM2 proteins, which form a complex that inhibits p53's transcriptional activity, resulting in reduced cell cycle arrest and apoptosis in cancer cells. By blocking the interaction between MDM2 and p53, these inhibitors prevent MDM2-mediated ubiquitination and degradation of p53. This leads to the stabilization and accumulation of p53, which can now initiate the transcription of target genes involved in cell cycle arrest and apoptosis. p53-MDM2 Interaction Inhibitors show promise in treating various cancers, including breast cancer, ovarian cancer, lung cancer, and glioblastoma. According to the World Health Organization (WHO), lung cancer is the most common cancer globally, with an estimated 2.2 million new cases each year. p53-MDM2 Interaction Inhibitors offer potential hope in improving the prognosis and survival rates of lung cancer patients. Research is being conducted globally to discover new and novel p53-MDM2 Interaction Inhibitors that function to regulate the levels of p53 protein to be used as anticancer agents. The development and launch of new products will thus increase the revenue of the p53-MDM2 Interaction Inhibitors market in the forecasted years. According to the American Cancer Society 2023 report, about 85% of all lung cancers are Non-small Cell Lung Cancer (NSCLC), with an estimated 238,340 new cases of lung cancers to be diagnosed in the USA in 2023.

Several of these inhibitors are on the market, while many are in ongoing clinical trials.  11 companies have various products in their pipelines, with 10 products in various stages of clinical trials. 2 products in Phase 3, 4 products in Phase 2, and 4 products are in Phase 1 of the clinical trials.

Drugs in Pipeline

  • Navtemadlin (KRT-232)
  • Idasanutlin (RG7388)
  • Siremadlin (HDM201)
  • Milademetan (RAIN-32)
  • Alrizomadlin (APG-115)
  • RG7112
  • UBX0101
  • MI-773
  • CGM097
  • RG7775

Clinical Activity and Developments of p53-MDM2 Interaction Inhibitors

As of June 2023, 11 companies have approximately 10 products for 7 diseases. For these diseases, 43 trials are being conducted by players globally. For instance,

  • Hoffmann-La Roche is conducting a Phase 2 clinical study to assess the Tumor Agnostic Precision Immuno-oncology and Somatic targeting rationale for TAPISTRY that is expected to complete it by September 2032.
  • Rain Oncology Inc. is conducting a Phase 3 clinical trial to evaluate the efficacy and safety of the treatment of Milademetan vs Trabectedin in patients with dedifferentiated Liposarcoma that is expected to complete by July 2025.
  • Rain Oncology Inc. is conducting a Phase 2 clinical trial to evaluate the efficacy and safety of Milademetan in Advanced/Metastatic Solid Tumors that is expected to complete by August 2024.

Molecule name

Number of studies

Navtemadlin (KRT-232)


Idasanutlin (RG7388)


Siremadlin (HDM201)


Milademetan (RAIN-32)


Alrizomadlin (APG-115)


Target Indication Analysis of p53-MDM2 Interaction Inhibitors

p53-MDM2 Interaction Inhibitors have shown promising potential in the treatment of various cancer types, making them a significant focus in oncology research. These inhibitors are particularly beneficial in targeting malignancies where the p53 pathway is impaired or compromised. Indications for which they find the most use include breast cancer, where they aim to restore p53 function and induce tumor regression. Additionally, lung cancer, one of the leading causes of cancer-related deaths worldwide, benefits from p53-MDM2 Interaction Inhibitors to activate apoptosis in cancer cells. Moreover, ovarian cancer and glioblastoma, both aggressive and challenging-to-treat cancers, demonstrate promising responses to these inhibitors, offering hope for improved patient outcomes. These inhibitors also hold potential in addressing leukemia, where restoration of p53 activity can hinder cancer cell proliferation. By selectively targeting the p53-MDM2 interaction, researchers strive to provide effective therapeutic options for these indications and revolutionize the cancer treatment landscape.

Key Features of the Reports

  • The report provides granular level information about the market size, regional market share, historic market (2018-2022), and forecast (2023-2029)
  • The report covers in-detail insights about the competitor’s overview, company share analysis, key market developments, and their key strategies
  • The report outlines drivers, restraints, unmet needs, and trends that are currently affecting the market
  • The report tracks recent innovations, key developments, and start-up details that are actively working in the market
  • The report provides a plethora of information about market entry strategies, regulatory framework, and reimbursement scenario

Frequently Asked Questions

Currently, no molecule has been approved by the FDA.

These are being used in various indications like Breast cancer, Ovarian cancer, Lung cancer, and others.

Kartos Therapeutics, Inc, Novartis, Hoffmann-La Roche, Sanofi and Rain Oncology are some of the major market players for p53-MDM2 Interaction Inhibitors.

Rising incidence of diseases, improvement in technologies, development of new treatment lines in the market, and changing lifestyles leading to disorders like Breast and Ovarian cancer are the key opportunities for p53-MDM2 Interaction Inhibitors in the market.

  • Kartos Therapeutics Inc
  • Hoffmann-La Roche
  • Novartis
  • Rain Oncology
  • Ascentage Pharma
  • Unity Biotechnology
  • Ascenta Pharma Group
  • Sanofi