Metastatic Prostate Cancer- Pipeline Insight, 2025

This “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.

Metastatic Prostate Cancer: Understanding

Metastatic Prostate Cancer: Overview

Metastatic prostate cancer marks an advanced stage of the disease where malignant cells originating in the prostate gland have disseminated to other areas of the body, typically via the bloodstream or lymphatic system. It represents a significant clinical challenge due to its potential to affect vital organs such as bones, lymph nodes, liver, and lungs. This stage of prostate cancer often presents with a distinct set of signs and symptoms. Common manifestations include bone pain, which may manifest as discomfort in the lower back, hips, or ribs, urinary symptoms like difficulty urinating or blood in the urine, erectile dysfunction, fatigue, unintended weight loss, and in severe cases, neurological symptoms such as weakness or numbness due to spinal cord compression by metastatic lesions.

Understanding the causes and pathophysiology of metastatic prostate cancer involves exploring various risk factors and the biological mechanisms underlying disease progression. While the precise etiology remains unclear, risk factors for prostate cancer include advanced age, family history, ethnicity, and genetic predisposition. Prostate cancer typically develops from the glandular cells of the prostate gland and progresses slowly over time. As the disease advances, cancer cells may invade surrounding tissues and eventually spread to distant sites. Metastatic dissemination commonly occurs in bones, as prostate cancer cells have a propensity to colonize the skeletal system, leading to debilitating bone pain and skeletal-related events.

Diagnosing metastatic prostate cancer relies on a combination of clinical evaluation, imaging studies, and pathological examination. Physicians may perform a digital rectal examination (DRE) to assess the prostate gland for abnormalities, alongside blood tests such as the prostate-specific antigen (PSA) test to measure PSA levels, which can indicate prostate cancer. Imaging modalities such as bone scans, CT scans, MRI scans, or PET scans play a crucial role in detecting metastases and assessing disease extent. A definitive diagnosis often involves a biopsy of the prostate gland or metastatic lesions, allowing for histopathological examination to confirm the presence of cancer cells and determine tumor characteristics.

Treatment strategies for metastatic prostate cancer aim to prolong survival, alleviate symptoms, and maintain quality of life. Common therapeutic approaches include hormone therapy, also known as androgen deprivation therapy (ADT), which reduces circulating androgen levels to inhibit cancer cell growth. Chemotherapy may be employed for more aggressive or advanced cases, while radiation therapy can target metastatic lesions to alleviate pain or prevent skeletal complications. Surgical interventions may include prostatectomy or palliative procedures to address specific symptoms. Additionally, novel therapies such as immunotherapy hold promise for enhancing the immune system's ability to recognize and eliminate cancer cells. Comprehensive management of metastatic prostate cancer often involves a multidisciplinary approach, integrating medical oncologists, radiation oncologists, urologists, and supportive care specialists to tailor treatment plans to individual patient needs and optimize outcomes.

'Metastatic Prostate Cancer- Pipeline Insight, 2025' report 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 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

TAVT-45: Tavanta Therapeutics

TAVT-45 is a novel oral suspension of abiraterone acetate. It was designed as an alternative abiraterone acetate formulation with clear benefits over branded Zytiga tablets. TAVT-45 granules are rapidly reconstituted in water or juice and easily consumed, which could aid the ~20-30% of patients who have dysphagia or difficulty swallowing.5,6 In clinical studies with TAVT-45, variability in abiraterone exposure was reduced compared to Zytiga, and bioavailability was enhanced in subjects in a fasted state. The improved absorption profile allows for a reduction in the total daily dose of TAVT-45 compared to Zytiga and may potentially improve exposure to therapeutic abiraterone concentrations over 24 h. The large food effect of Zytiga is also avoided, and it is anticipated TAVT-45 to be dosed without regard to meals.

The pivotal Phase 3 trial met its primary objective of establishing therapeutic equivalence of TAVT-45 to Zytiga in patients with metastatic castrate-resistant prostate cancer and metastatic high-risk castrate-sensitive prostate cancer, in addition to demonstrating a comparable safety profile.7 The NDA is under preparation. Tavanta is currently evaluating strategic options for this asset, an easy-to-swallow alternative to Zytiga, intended for patients with metastatic prostate cancer who have difficulty swallowing. Currently, the drug is in Phase III stage of its development for the treatment of prostate cancer.

Onvansertib: Cardiff Oncology

Onvansertib is a first-in-class, third-generation, oral and highly-selective adenosine triphosphate (ATP) competitive inhibitor of the serine/threonine polo-like-kinase 1 (PLK1) enzyme, which is over-expressed in multiple cancers including leukemias, lymphomas and solid tumors. Onvansertib targets the PLK1 isoform only (not PLK2 or PLK3), is orally administered and has a 24-hour half-life with only mild-to-moderate side effects reported. Currently, the drug is in Phase II stage of its development for the treatment of prostate cancer.

ONCT-534: Oncternal Therapeutics

ONCT-534, Dual-Action Androgen Receptor Inhibitor (DAARI) candidate, is a novel investigational, potentially first-in-class, orally bioavailable, dual-action androgen receptor (AR) inhibitor, designed to treat patients with metastatic castration-resistant prostate cancer and other androgen receptor-driven diseases. Currently, the drug is in Phase I/II stage of its development for the treatment of prostate cancer.

VIO-01: Valerio Therapeutics

VIO-01 is designed to abrogate several DNA repair pathways and trigger a robust immune response by activating the innate immune response through the STING pathway. The STING pathway plays a critical role in detecting DNA abnormalities and activating the immune system to target and destroy cancer cells. VIO-01 is currently undergoing proof-of-concept IND-enabling preclinical studies, alone and in combination with cancer immunotherapies. Currently, the drug is in Phase I/II stage of its development for the treatment of prostate cancer.

ORIC-944: ORIC Pharmaceuticals

ORIC-944 is a potent, orally bioavailable, highly selective allosteric small molecule inhibitor of PRC2, the complex which tri-methylates histone H3 lysine 27 (H3K27me3) via targeting the embryonic ectoderm development (EED) subunit. Currently, the drug is in Phase I stage of its development for the treatment of prostate cancer.

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 III include, Tavanta Therapeutics.

Phases

The 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 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?

Key Players

• Tavanta Therapeutics
• Cardiff Oncology
• Oncternal Therapeutics
• Valerio Therapeutics
• ORIC Pharmaceuticals
• Telix Pharmaceuticals (Innovations) Pty Limited
• Orion Corporation
• OncoC4, Inc.

Bristol-Myers Squibb/Ono Pharmaceuticals

• Janssen Research & Development, LLC
• Merck Sharp & Dohme LLC
• Modra Pharmaceuticals
• Minneamrita Therapeutics LLC
• AB Science
• Cellbion Co., Ltd.

Allarity Therapeutics

• Janssen Research & Development, LLC
• Hansoh BioMedical R&D Company
• Jiangsu HengRui Medicine Co., Ltd.

Hinova Pharmaceuticals Inc

• ValiRx Plc
• Epizyme, Inc.

Astrazeneca

Key Products

• TAVT-45
• Onvansertib
• ONCT-534
• VIO-01
• ORIC-944
• 177Lu-DOTA-rosopatamb
• ODM-209
• ONC-392
• Opevesostat
• Niraparib
• Navarixin
• ModraDoc006/r
• Minnelide 101
• Masitinib
• Lu-177-DGUL
• LiPlaCis
• JNJ-78278343
• JNJ-75229414
• HS-20093
• HRS-5041
• HP518
• Deutenzalutamide
• Nivolumab
• VAL201
• Tazemetostat
• Saruparib

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