STAT Inhibitors - Pipeline Insight, 2025

This “STAT Inhibitors - Pipeline Insight, 2025” report provides comprehensive insights about 20+ companies and 25+ pipeline drugs in STAT Inhibitors pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

STAT Inhibitors: Understanding

STAT Inhibitors: Overview

Signal Transducer and Activator of Transcription (STAT) proteins are a family of cytoplasmic transcription factors consisting of 7 members, STAT1 to STAT6, STAT5a and STAT5b. They are activated either by receptor associated tyrosine kinases like Janus kinases (JAKs) or by receptors with intrinsic tyrosine kinase activity e.g. PDGFR, EGFR, FLT3. They can also be activated by constitutively active non-receptor protein tyrosine kinases (PTKs), such as c-Src Bcr-Abl, and Brk (Breast tumor kinase). Specific phosphorylation of STAT proteins by these tyrosine kinases causes their homo- or hetero-dimerization. These dimers then migrate to the nucleus to control gene expression. STAT family is composed of STAT1, STAT2, STAT3, STAT4, STAT5a, STAT5b, and STAT6. STAT family members consist of 750-900 amino acids. From the N-terminus to the C-terminus, there are the N-terminal domain and coil, helix domain, DNA-binding domain, connection domain, SH2 domain, and transcription-activation domain. Six domains regulate different functions of STAT. The N-terminal domain promotes the formation of STAT dimers, which enables their subsequent binding with transcription factors.The coiled-coil domain is composed of a potentially dynamic four-helix bundle. This domain is related to regulatory proteins and participates in the control of nuclear import and export processes.

The linking domain, as the name implies, structurally connects the DNA-binding domain to the SH2 domain. It is involved in the transcriptional regulation of STAT1. The DNA-binding domain can recognize and bind to the DNA sequence in the regulatory region of the target gene. It also participates in the regulation of nuclear import and export. (5) The SH2 domain of STAT is very different from other SH2 domains, but this domain is much conserved in the STAT family. The transcriptional activation domain is critical for DNA transcription elements and the recruitment of co-activators through a conserved serine phosphorylation site and regulating the transcription.

STAT4, STAT5, and STAT6 can be used as targets for ubiquitin-dependent destruction, while STAT1, STAT2, and STAT3 are more stable, indicating that the transcriptional active region also regulates protein stability. The JAK/STAT signaling pathway is an universally expressed intracellular signal transduction pathway and involved in many crucial biological processes, including cell proliferation, differentiation, apoptosis, and immune regulation. JAK/STAT pathways are major signaling channels for transmitting extracellular signals into the nuclei of cells. Monoclonal antibodies have been developed to target the signaling molecules along the related pathways. In addition, small molecule inhibitors of JAK and Kit are widely used in cancer therapy. Inhibitors targeting STAT molecules, particularly STAT3 and STAT5, are under intensive studies.

'STAT Inhibitors - Pipeline Insight, 2025' report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the STAT Inhibitors pipeline landscape is provided which includes the disease overview and STAT Inhibitors treatment guidelines. The assessment part of the report embraces, in depth STAT Inhibitors commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, STAT Inhibitors collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

The companies and academics are working to assess challenges and seek opportunities that could influence STAT Inhibitors R&D. The therapies under development are focused on novel approaches to treat/improve STAT Inhibitors.

STAT Inhibitors Emerging Drugs Chapters

This segment of the STAT Inhibitors report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

STAT Inhibitors Emerging Drugs

SHR0302: Jiangsu HengRui Medicine Co., Ltd

SHR0302 is a potent and highly selective Janus kinase type 1 (JAK1) inhibitor. Several late-stage clinical studies are on-going with both oral and topical dosage forms for several immune-inflammatory diseases including atopic dermatitis, alopecia areata vitiligo, ulcerative colitis, and Crohn's disease. The high selectivity of SHR0302 may potentially provide a favorable safety and efficacy profile compared to the pan-JAK inhibitors. SHR0302 was granted Breakthrough Therapy designation by China's CDE for treatment in atopic dermatitis in January 2021. Currently, the drug is in Preregistration stage of its development for the treatment of Atopic dermatitis.

• ANA001: NeuroBo Pharmaceuticals

ANA001 is a proprietary oral niclosamide formulation in development as a treatment for patients with COVID-19. Niclosamide has antiviral and anti-inflammatory properties, and a well-understood safety profile in humans. ANA001 is currently being studied in a 60-subject Phase II clinical trial conducted in the U.S. Niclosamide has demonstrated both antiviral and immunomodulatory activity with possible downstream effects on coagulation abnormalities observed in COVID-19. In preclinical research by an independent academic group published in Antimicrobial Agents and Chemotherapy, niclosamide inhibited viral replication in vitro and was more potent than remdesivir in the same assay. Currently, the drug is in Phase II/III stage of its development for the treatment of COVID infections.

NT219: Purple Biotech

NT219 is a first-in-class, small molecule that promotes Insulin Receptor Substrates 1/2 (IRS) degradation and inhibits Signal Transducer and Activator of Transcription 3 (STAT3) phosphorylation, two major complementary signaling pathways that play a key role in the tumor and its microenvironment. IRS1/2 acts as scaffolds, organizing signaling complexes that mediate mitogenic, metastatic, angiogenic, and anti-apoptotic signals from IGF1R and other oncogenes, consisting of an important driver in multiple cancers and is highly involved in triggering drug resistance. STAT3 is a transcription factor that is broadly hyper activated in many cancers, promoting proliferation, survival, angiogenesis, metastasis, and tumor immune evasion. Feedback activation of STAT3 plays a prominent role in mediating drug resistance to various anti-cancer therapies. As an inhibitor of both IRS1/2 and STAT3, NT219 has the potential to prevent the development of resistance to multiple approved therapies. Currently, the drug is in Phase I/II stage of its development for the treatment of colorectal cancer.

STAT Inhibitors: Therapeutic Assessment

This segment of the report provides insights about the different STAT Inhibitors drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in STAT Inhibitors

• There are approx. 20+ key companies which are developing the therapies for STAT Inhibitors. The companies which have their STAT Inhibitors drug candidates in the most advanced stage, i.e. preregistration include, Jiangsu HengRui Medicine Co., Ltd

Phases

The report covers around 25+ products under different phases of clinical development like

• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

Route of Administration

STAT Inhibitors pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

Molecule Type

Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

STAT Inhibitors: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses STAT Inhibitors therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging STAT Inhibitors drugs.

STAT Inhibitors Report Insights

• STAT Inhibitors Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

STAT Inhibitors Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing STAT Inhibitors drugs?
• How many STAT Inhibitors drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of STAT Inhibitors?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the STAT Inhibitors therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for STAT Inhibitors and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Jiangsu HengRui Medicine Co., Ltd
• NeuroBo Pharmaceuticals
• Purple Biotech
• Vividion Therapeutics
• WPD Pharmaceuticals
• Recludix Pharma
• Hyundai Bioscience
• ANA Therapeutics
• UNION Therapeutics
• Tvardi Therapeutics
• Proteovant Therapeutics

Key Products

• SHR0302
• ANA001
• NT219
• Rsearch programme: STAT3 inhibitor
• WP 1066
• REX 5376
• Niclosamide
• Niclosamide capsules
• Niclosamide
• TTI 101
• Research programme: STAT3 inhibitors

This product will be delivered within 1-3 business days.