Metastatic Hormone Refractory Prostate Cancer - Pipeline Insight, 2025

DelveInsight's, "Metastatic Hormone Refractory Prostate Cancer - Pipeline Insight, 2025" report provides comprehensive insights about 180+ companies and 200+ pipeline drugs in Metastatic Hormone Refractory 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 Hormone Refractory Prostate Cancer: Understanding

Metastatic Hormone Refractory Prostate Cancer: Overview

Metastatic Hormone-Refractory Prostate Cancer (mHRPC), also known as metastatic castration-resistant prostate cancer (mCRPC), is an advanced stage of prostate cancer in which the disease continues to progress despite the suppression of testosterone to castrate levels. Initially, prostate cancer growth is typically driven by androgens, and hormone therapy is effective in slowing or stopping the disease. However, in mHRPC, cancer cells adapt and continue to grow even in the low-androgen environment. The cancer has also spread beyond the prostate gland to distant sites, most commonly bones and lymph nodes. This stage is associated with more aggressive behavior, increased symptom burden, and limited treatment options, requiring systemic therapies aimed at prolonging survival and improving quality of life.

Metastatic Hormone-Refractory Prostate Cancer (mHRPC) presents with a range of symptoms, primarily related to the spread of cancer beyond the prostate. Common signs include persistent bone pain, especially in the back, hips, or ribs, which is often due to bone metastases. Patients may also experience fatigue, weight loss, and general weakness. Urinary symptoms such as difficulty urinating, increased frequency, or hematuria can persist or worsen. As the disease progresses, spinal cord compression, fractures, and anemia may occur, along with swelling in the legs due to lymphatic obstruction. These symptoms can significantly affect quality of life and often indicate the need for more intensive systemic treatment. In advanced stages, patients may also report neurological symptoms like numbness or tingling if the cancer compresses nerves. Loss of appetite and unintentional weight loss are common systemic manifestations. Difficulty walking or maintaining balance may occur if spinal metastases are present. Additionally, increased calcium levels in the blood (hypercalcemia) can lead to confusion, constipation, and dehydration in some individuals.

Metastatic Hormone-Refractory Prostate Cancer (mHRPC), also known as metastatic Castration-Resistant Prostate Cancer (mCRPC), arises when prostate cancer cells continue to grow and spread despite suppression of androgenic hormones, which typically fuel their growth. Initially responsive to androgen deprivation therapy (ADT), the cancer eventually becomes resistant through various mechanisms such as androgen receptor (AR) amplification, mutations in the AR gene, intratumoral androgen synthesis, and activation of alternative signaling pathways. These adaptations allow cancer cells to sustain growth even in low-testosterone environments. As the disease progresses, tumor cells gain the ability to metastasize to distant organs-most commonly bones, lymph nodes, lungs, and liver-further complicating the clinical course. Bone metastases are particularly common and contribute significantly to morbidity due to skeletal-related events such as fractures and spinal cord compression.

The treatment and management of Metastatic Hormone-Refractory Prostate Cancer (mHRPC), or metastatic Castration-Resistant Prostate Cancer (mCRPC), involve a multimodal approach aimed at slowing disease progression, alleviating symptoms, and improving quality of life. Therapeutic strategies include next-generation androgen receptor signaling inhibitors such as enzalutamide and abiraterone, which target residual androgen activity despite castration. Chemotherapy agents like docetaxel and cabazitaxel are used in more advanced or rapidly progressing cases. Treatment is individualized based on disease burden, patient health status, prior therapies, and genomic alterations.

"Metastatic Hormone Refractory 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 Hormone Refractory Prostate Cancer pipeline landscape is provided which includes the disease overview and Metastatic Hormone Refractory Prostate Cancer treatment guidelines. The assessment part of the report embraces, in depth Metastatic Hormone Refractory 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 Hormone Refractory 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 Hormone Refractory Prostate Cancer R&D. The therapies under development are focused on novel approaches to treat/improve Metastatic Hormone Refractory Prostate Cancer.

Metastatic Hormone Refractory Prostate Cancer Emerging Drugs Chapters

This segment of the Metastatic Hormone Refractory 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 Hormone Refractory Prostate Cancer Emerging Drugs

• PNT2002: Lantheus

A radioconjugate composed of PNT2002, a human prostate-specific membrane antigen (PSMA)-targeting ligand, conjugated to the beta-emitting radioisotope lutetium Lu 177 (177Lu), with potential antineoplastic activity. Upon administration of lutetium Lu-177 PNT2002, the PNT2002 moiety targets and binds to PSMA-expressing tumor cells. Upon binding, PSMA-expressing tumor cells are destroyed by 177Lu through the specific delivery of beta particle radiation. PSMA, a tumor-associated antigen (TAA) and type II transmembrane protein, is expressed on the membrane of prostatic epithelial cells and overexpressed on the majority of prostate tumor cells. The FDA has also granted fast track designation to the prostate specific membrane antigen (PSMA)-targeted therapy, 177Lu-PNT2002, for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). Currently, the drug is in Phase III stage of its development for the treatment of Metastatic Hormone Refractory Prostate Cancer.

• 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 Hormone Refractory Prostate Cancer.

• XL092: Exelixis

XL092 is a next-generation oral TKI that inhibits the activity of receptor tyrosine kinases implicated in cancer growth and spread, including VEGF receptors, MET, AXL and MER. These receptor tyrosine kinases are involved in both normal cellular function and in pathologic processes such as oncogenesis, metastasis, tumor angiogenesis, and resistance to multiple therapies, including immune checkpoint inhibitors. XL092 is currently being developed for the treatment of advanced solid tumors, including genitourinary cancers, as a monotherapy and in combination with immune checkpoint inhibitors. Currently, the drug is in Phase II stage of its development for the treatment of Metastatic Hormone Refractory Prostate Cancer.

• ZEN 3694: Zenith Epigenetics

ZEN-3694 is an orally bioavailable, potent, small molecule BET inhibitor that selectively binds to both bromodomains of the BET proteins. The drug candidate was discovered and developed from a BET bromodomain inhibitor platform. Bromodomain and Extra-Terminal domain (BET) family of proteins (BRD2, BRD3, BRD4, and BRDT) can bind acetylated lysines through their tandem bromodomains to promote gene transcription. BET bromodomain inhibitors (BETi) target super enhancers and inhibit several programs involved in tumorigenesis such as proliferation, metastasis, invasion, and immune evasion. Currently, the drug is in Phase II stage of its development for the treatment of Metastatic Hormone Refractory Prostate Cancer.

• CCS1477: CellCentric

Inobrodib is a small molecule inhibitor, taken orally as a capsule. It inhibits p300 and CBP through binding into the conserved bromodomain of the twin proteins. This impacts the expression of key cancer drivers, including MYC and IRF4. Different cancer indications can be targeted by inobrodib as monotherapy or in combination with existing standard of care drugs. Currently, the drug is in Phase I/II stage of its development for the treatment of Metastatic Hormone Refractory Prostate Cancer.

• KPT-8602: Karyopharm Therapeutics

Eltanexor (KPT-8602) is a second generation oral SINE compound. Eltanexor functions by binding to and inhibiting the nuclear export protein XPO1 (also called CRM1), leading to the accumulation of tumor suppressor proteins in the cell nucleus. Eltanexor has demonstrated minimal brain penetration in animals, which has been associated with reduced toxicities in preclinical studies while maintaining potent anti-tumor effects. Currently, the drug is in Phase I/II stage of its development for the treatment of Metastatic Hormone Refractory Prostate Cancer.

• JANX 007: 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 Hormone Refractory Prostate Cancer.

• PF07248144: Pfizer

PF-07248144, developed by Pfizer, is a small molecule antineoplastic agent that functions as a histone acetyltransferase (HAT) inhibitor. By inhibiting HAT, it potentially disrupts gene expression and cellular processes that promote cancer growth. Its mechanism of action targets the modification of histones, a key process in epigenetic regulation. Currently, the drug is in Phase I stage of its development for the treatment of Metastatic Hormone Refractory Prostate Cancer.

Metastatic Hormone Refractory Prostate Cancer: Therapeutic Assessment

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

• Major Players in Metastatic Hormone Refractory Prostate Cancer
• There are approx. 180+ key companies which are developing the therapies for Metastatic Hormone Refractory Prostate Cancer. The companies which have their Metastatic Hormone Refractory Prostate Cancer drug candidates in the most advanced stage, i.e. Phase III include, Lantheus.
• Phases

DelveInsight's report covers around 200+ 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 Hormone Refractory 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 Hormone Refractory 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 Hormone Refractory 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 Hormone Refractory Prostate Cancer drugs.

Metastatic Hormone Refractory Prostate Cancer Report Insights

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

Metastatic Hormone Refractory 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 Hormone Refractory Prostate Cancer drugs?
• How many Metastatic Hormone Refractory 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 Hormone Refractory Prostate Cancer?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Metastatic Hormone Refractory 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 Hormone Refractory Prostate Cancer and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Lantheus
• Merck
• Exelixis
• Zenith Epigenetics
• CellCentric
• Karyopharm Therapeutics
• Janux Therapeutics
• Pfizer
• Tavanta Therapeutics
• Telix Pharmaceuticals
• Jiangsu HengRui Medicine
• SOTIO
• Antev Ltd.
• Syntrix Pharmaceuticals
• Regeneron Pharmaceuticals
• Madison Vaccines
• Phosplatin Therapeutics
• MacroGenics
• RedHill Biopharma
• Xencor

Key Products

• PNT2002
• Opevesostat
• XL092
• ZEN 3694
• CCS1477
• KPT-8602
• JANX 007
• PF07248144
• TAVT-45
• TX591
• Fluzoparib
• DCVAC/PCa
• Teverelix-TFA
• SX-682
• REGN5678
• MVI-118
• PT-112
• MGC018
• Opaganib
• Vudalimab