P53 Stimulators Market: Competitive Landscape, Pipeline, and Market Analysis 2024

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p53, also known as Tumor protein P53, cellular tumor antigen p53, or transformation-related protein 53 (TRP53), is a regulatory protein often mutated in human cancers. The TP53 gene is the most frequently mutated gene (>50%) in human cancer, indicating that the TP53 gene plays a crucial role in preventing cancer formation. TP53 gene encodes proteins that bind to DNA and regulate gene expression to prevent mutations in the genome. p53 Stimulators are a class of compounds or drugs that aim to activate the tumor suppressor protein known as p53. p53 is a critical protein that regulates cell growth and prevents cancer development. It acts as a transcription factor, which controls the expression of various genes involved in cell cycle arrest, DNA repair, and apoptosis (programmed cell death). The mechanism of action of p53 Stimulators can vary depending on the specific compound. However, the general principle is to enhance the activity or stability of the p53 protein, thereby promoting its tumor suppressor functions.

The p53 Stimulators treat lymphoma, brain diseases, urogenital neoplasms, adrenal diseases, astrocytoma, digestive system disorders, endocrine gland disorders, fallopian tube disorders, genetic diseases, and glioma. The increased prevalence of sarcoma and lymphoma are the critical drivers for the P53 Stimulators market. For instance, According to the International Agency for Research on Cancer (IARC), which is part of the WHO, head and neck cancer is the seventh most common cancer globally. It accounts for an estimated 4% of all cancer cases worldwide. The launch of newer products by the market players could seek opportunities that influence extensive research and development in  p53 Stimulators. For instance, Mergen Ltd launched Oncorine (Recombinant Human Adenovirus Type 5) to treat head and neck cancer. Moreover, the development of novel molecules by many market players is coming up to overcome challenges in therapy. For instance, Lumos Pharma’s INGN 225 for lung cancer treatment is in the various stages of clinical studies.

Key Market Developments:

In February 2018, Innovation Pharmaceuticals completed a phase 2 study of Kevetrin (Thioureidobutyronitrile) in subjects with platinum-resistant/refractory ovarian cancer.

Approved Drug Molecules and Brand Names for P53 Stimulators:

  • Oncorine (Recombinant Human Adenovirus Type 5)- (approved in China)
  • Gendicine (Rad-P53 Gene Therapy)- (approved in China)

Drugs under the Pipeline for P53 Stimulators:

  • INGN 225
  • SGT-53
  • CBL137 IV
  • p53MVA
  • Ad-p53 Gene Therapy
  • BTX-A51
  • Kevetrin (Thioureidobutyronitrile)
  • Quinacrine (CBL0102)
  • ADXS-503
  • CBL0137 IA
  • COTI-2

Clinical Activity and Developments of P53 Stimulators:

Till July 2023, more than ten companies have approximately 13 molecules for various cancers. For these molecules, more than 20 clinical trials are being conducted, and most are in phase-2 and phase-3 clinical trials by players across the globe. For instance,

  • In February 2019, Lumos Pharma completed phase 2, a randomized phase ii trial using dendritic cells transduced with an adenoviral vector containing the p53 gene to immunize patients with extensive-stage small cell lung cancer in combination with chemotherapy with INGN 225 (Primary), Paclitaxel, and Tretinoin.

Molecule  Name

Number of Studies

INGN 225








Ad-p53 Gene Therapy


Target Indication Analysis of P53 Stimulators

The molecules such as Oncorine (Recombinant Human Adenovirus Type 5) developed by Mergen Ltd is the first recombinant oncolytic virus therapy approved by the Chinese state FDA and used with chemotherapy to treat head and neck cancer. Moreover, Benda Pharma’s Gendicine (Rad-P53 Gene Therapy) is the first approved viral vector-based gene therapy drug for the treatment of head and neck cancer.

Frequently Asked Questions

Oncorine (Recombinant Human Adenovirus Type 5), Gendicine (Rad-P53 Gene Therapy) are the few approved P53 Stimulators in China.

Gendicine and Oncorine are only sold in China with combined sales of USD 8 million in FY2017.

Mergen Ltd., Benda Pharma, Lumos Pharma, etc are a few leading market players in P53 Stimulators.

Major Indications for P53 Stimulators are lymphoma, brain diseases, urogenital neoplasms, adrenal diseases, astrocytoma, digestive system disorders, endocrine gland disorders, fallopian tube disorders, genetic diseases, etc.

There are a total of 11 molecules that are in Phase-1, Phase-2 and Phase-3 clinical development.

Key Features of the Reports

  • The report provides granular level information about the market size, regional market share, historic market (2019-2023), and forecast (2024-2030)
  • 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
  • Mergen Ltd.
  • Benda Pharma
  • Lumos Pharma
  • SynerGene Therap
  • Tara I-O
  • MultiVir
  • BioTheryX
  • Innovation Pharma
  • Ayala Pharma
  • Incuron
  • Statera BioPharma
  • Cotinga Pharma

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