Metastatic Prostate Cancer Pipeline

DelveInsight’s, “Metastatic Prostate Cancer - Pipeline Insight, 2025” report provides comprehensive insights about 80+ companies and 85+ pipeline drugs in Metastatic Prostate Cancer 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.

 

Geography Covered

• Global coverage

 

Metastatic Prostate Cancer: Understanding

Metastatic Prostate Cancer: Overview

Metastatic prostate cancer (mPC) represents the advanced stage of prostate cancer where the disease has spread beyond the prostate gland, often to bones or lymph nodes, and is associated with significantly worse outcomes. Standard treatments for metastatic hormone-sensitive prostate cancer (mHSPC) include androgen deprivation therapy (ADT), androgen receptor signaling inhibitors (ARSIs), and chemotherapy. Despite initial responsiveness, most patients eventually progress to metastatic castration-resistant prostate cancer (mCRPC), which has a poor prognosis. Recent advancements, such as PARP inhibitors and radioligand therapies, have expanded treatment options, though immunotherapy has shown limited efficacy due to the immunologically “cold” tumor microenvironment. Novel approaches, including bispecific T-cell engagers targeting PSMA, are being explored to enhance immune response and improve outcomes in this challenging disease setting.

 

Metastatic prostate cancer, also known as advanced prostate cancer, occurs when cancer originating in the prostate spreads to other parts of the body, most commonly the bones or lymph nodes. Common signs and symptoms include persistent bone pain, extreme fatigue, unexplained weight loss, and a general feeling of being unwell. Depending on the site of metastasis, additional symptoms may arise, such as swelling in the legs or difficulty urinating. These symptoms can overlap with those of other medical conditions, so further investigation is often needed to confirm cancer progression.

 

The pathophysiology of metastatic prostate cancer involves the progression of malignant prostate cells beyond the gland through local invasion, lymphatic spread, or hematogenous dissemination, most commonly to bones. This process is driven by androgen receptor signaling, which promotes tumor growth and survival. Over time, tumor cells can adapt to low-androgen environments, leading to castration-resistant prostate cancer (CRPC). Molecular alterations, such as mutations in DNA repair genes (e.g., BRCA1/2), activation of oncogenic pathways, and immune evasion mechanisms, contribute to disease progression and resistance to therapy. The bone microenvironment is especially conducive to prostate cancer metastasis due to complex interactions between tumor cells, osteoblasts, and osteoclasts, resulting in characteristic osteoblastic lesions.

 

Treatment of metastatic prostate cancer depends on whether the disease is hormone-sensitive (mHSPC) or castration-resistant (mCRPC). Androgen deprivation therapy (ADT) remains the cornerstone of treatment, often combined with androgen receptor signaling inhibitors (ARSIs) such as abiraterone, enzalutamide, or apalutamide to improve survival. Chemotherapy, typically with docetaxel, is used in more aggressive or high-volume disease. In mCRPC, additional options include PARP inhibitors for patients with DNA repair gene mutations, radioligand therapies targeting prostate-specific membrane antigen (PSMA), and second-line chemotherapy. While immunotherapies have shown limited success due to the tumor’s immune-cold microenvironment, novel approaches like bispecific T-cell engagers and therapeutic cancer vaccines are being investigated to enhance immune response and overcome resistance.

 

"Metastatic Prostate Cancer- Pipeline Insight, 2025" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Metastatic Prostate Cancer pipeline landscape is provided which includes the disease overview and Metastatic Prostate Cancer treatment guidelines. The assessment part of the report embraces, in depth Metastatic Prostate Cancer 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, Metastatic Prostate Cancer 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 Metastatic Prostate Cancer R&D. The therapies under development are focused on novel approaches to treat/improve Metastatic Prostate Cancer.

 

Metastatic Prostate Cancer Emerging Drugs Chapters

This segment of the Metastatic Prostate Cancer report encloses its detailed analysis of various drugs in different stages of clinical development, including Phase III, 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.

 

Metastatic Prostate Cancer Emerging Drugs

• Opevesostat: Merck

Opevesostat is an oral, non-steroidal and selective inhibitor of the CYP11A1 enzyme discovered and developed by Orion for the treatment of hormone-dependent cancers, such as prostate cancer. By inhibiting CYP11A1 enzyme activity, ODM-208 is designed to suppress the production of all steroid hormones and their precursors that may activate the androgen receptor signaling pathway. Currently, the drug is in Phase III stage of its development for the treatment of Metastatic Prostate Cancer.

 

• AZD5305: AstraZeneca

AZD5305 is a highly potent and selective inhibitor of PARP1 with 500-fold selectivity for PARP1 over PARP2. When PARP1 is inhibited, it leads to the accumulation of DNA damage, particularly in cells lacking functional HRR pathways. This results in cell death due to the inability to repair critical DNA lesions. AZD5305 inhibits growth in cells with deficiencies in DNA repair, with minimal/no effects in other cells. Currently, the drug is in Phase III stage of its development for the treatment of Metastatic Prostate Cancer.

 

• SX-682: Syntrix Pharmaceuticals

SX-682 is a potent small-molecule dual-inhibitor of CXCR1 and CXCR2, chemokine receptors pivotal to myeloid cell suppression of cancer surveillance by the adaptive immune system.  By blocking the CXCR1/2 pathway, SX-682 inactivates immunosuppressive myeloid cells, thereby cutting off “at the source” dozens of downstream pro-tumor mechanisms mediated by these cells.  The inactivation of suppressive myeloid cells liberates effector cells to kill and eliminate cancer cells. Currently, the drug is in Phase II stage of its development for the treatment of Metastatic Prostate Cancer.

 

• Onvansertib: Cardiff Oncology

Onvansertib is a first-in-class, third generation, highly selective, oral Polo like Kinase 1 (PLK1) inhibitor, that is designed to target and inhibit cancer cell division (mitosis). It is an orally bioavailable, adenosine triphosphate (ATP) competitive inhibitor of polo-like kinase 1 (PLK1; PLK-1; STPK13), with potential antineoplastic activity. Upon administration, Onvansertib selectively binds to and inhibits PLK1, which disrupts mitosis and induces selective G2/M cell-cycle arrest followed by apoptosis in PLK1-overexpressing tumor cells. PLK1, named after the polo gene of Drosophila melanogaster, is a serine/threonine kinase that is crucial for the regulation of mitosis, and plays a key role in tumor cell proliferation. PLK1 expression is upregulated in a variety of tumor cell types and high expression is associated with increased aggressiveness and poor prognosis. Currently, the drug is in Phase II stage of its development for the treatment of Metastatic Prostate Cancer.

 

• JANX007: Janux Therapeutics

JANX007 is lead novel Tumor Activated T Cell Engager (TRACTr). JANX007 is designed to target PSMA, a protein expressed in prostate cancer tumors and the vasculature of tumors and is in the clinic for the treatment of metastatic castration-resistant prostate cancer (mCRPC). The company designed PSMA-TRACTr drug candidate as a single-masked TRACTr in which the PSMA-binding domain is unmasked. The T cell-specific binding domain (CD3e) is masked to help minimize CRS. Currently, the drug is in Phase I stage of its development for the treatment of Metastatic Prostate Cancer.

 

• ORIC-944: ORIC Pharmaceuticals, Inc

ORIC-944 is a potent and selective allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the embryonic ectoderm development (EED) subunit that demonstrates best-in-class drug properties in preclinical studies, including potency, solubility, and pharmacokinetics, with half-life supporting once daily dosing. ORIC-944 was initially evaluated as a single agent in a Phase Ib trial in patients with advanced prostate cancer and demonstrated potential best-in-class drug properties, including clinical half-life of approximately 20 hours, robust target engagement and a favorable safety profile. Currently, the drug is in Phase I stage of its development for the treatment of Metastatic Prostate Cancer.

Further product details are provided in the report……..

Metastatic Prostate Cancer: Therapeutic Assessment

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

Major  Players in Metastatic Prostate Cancer

There are approx. 80+ key companies which are developing the therapies for Metastatic Prostate Cancer. The companies which have their Metastatic Prostate Cancer drug candidates in the most advanced stage, i.e. Phase II include, Merck.

 

Phases

DelveInsight’s report covers around 85+ 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

Metastatic Prostate Cancer 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.

 

Metastatic Prostate Cancer: Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, II, I, preclinical and discovery stage. It also analyses Metastatic Prostate Cancer 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 Metastatic Prostate Cancer drugs.

 

Metastatic Prostate Cancer Report Insights

• Metastatic Prostate Cancer Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Metastatic Prostate Cancer 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 Metastatic Prostate Cancer drugs?
• How many Metastatic Prostate Cancer drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Metastatic Prostate Cancer?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Metastatic Prostate Cancer 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 Metastatic Prostate Cancer and their status?
• What are the key designations that have been granted to the emerging drugs?