Metastatic Urothelial Carcinoma- Pipeline Insight, 2025

DelveInsight’s, “Metastatic Urothelial Carcinoma- Pipeline Insight, 2025” report provides comprehensive insights about 40+ companies and 40+ pipeline drugs in Metastatic Urothelial Carcinoma 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 Urothelial Carcinoma: Understanding

Metastatic Urothelial Carcinoma: Overview

Urothelial carcinoma is the sixth most common malignancy in the US. Bladder cancer (with urothelial carcinoma accounting for 90% of bladder tumors in the USA) is the most common malignancy of the urinary tract system and the sixth most common cancer in the USA, with an estimated 79,030 cases to be diagnosed in 2017. Urothelial carcinoma, also known as transitional cell carcinoma (TCC), is by far the most common type of bladder cancer. In fact, if a person have bladder cancer it's almost certain to be a urothelial carcinoma. These cancers start in the urothelial cells that line the inside of the bladder. Urothelial cells also line other parts of the urinary tract, such as the part of the kidney that connects to the ureter (called the renal pelvis), the ureters, and the urethra. People with bladder cancer sometimes have tumors in these places, too, so all of the urinary tract needs to be checked for tumors. Other types of cancer can start in the bladder, but these are all much less common than urothelial (transitional cell) cancer. Approximately 25 percent of patients will have muscle-invasive disease and either present with or later develop metastases. Systemic chemotherapy is the standard approach for the initial treatment of patients with inoperable locally advanced or metastatic urothelial malignancies. Although initial response rates are high, the median survival with multiagent chemotherapy is approximately 15 months. While this is superior to the estimated six-month survival with metastatic disease prior to the development of modern chemotherapy regimens, the five-year survival rate is approximately 15 percent with contemporary regimens. Second-line chemotherapy has had only a limited role, but checkpoint inhibitor immunotherapy offers an additional option for patients progressing after their initial systemic therapy.The approach to systemic treatment for metastatic urothelial carcinoma arising in the renal pelvis or ureter is based on results from trials composed primarily of patients with urothelial carcinoma of the bladder. Regimens used in the treatment of metastatic urothelial carcinoma include the following: GC – Gemcitabine (1000 mg/m2 on days 1, 8, 15) plus cisplatin (70 mg/m2 on day 2), repeated every 28 days for a maximum of six cycles, MVAC – Methotrexate (30 mg/m2 on days 1, 15, and 22), vinblastine (3 mg/m2 on days 2, 15, and 22), doxorubicin (30 mg/m2 on day 2), and cisplatin (70 mg/m2 on day 2), repeated every 28 days for six cycles, PGC – Paclitaxel (80 mg/m2 before gemcitabine and cisplatin on days 1 and 8), gemcitabine (1000 mg/m2 on days 1 and 8), and cisplatin (70 mg/m2 on day 1), repeated every 21 days for a maximum of six cycles. Molecular analysis has identified genetic and epigenetic alterations in high-grade urothelial carcinomas, and up to 60 percent of these alterations can be targeted by drugs already approved for use in other indications or in clinical trials.

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

Metastatic Urothelial Carcinoma Emerging Drugs Chapters

This segment of the Metastatic Urothelial Carcinoma 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 Urothelial Carcinoma Emerging Drugs

• MFA 370: Ectin Research AG

Urothelial bladder cancer is one of the world’s most aggressive cancers, current treatments can be tough to tolerate. MFA-370 is planned to be a simple oral tablet developed to eliminate tumors safely, with few if any side effects. MFA-370 is a combination of a medication from that substance family, together with one other standard, well-established drug. Both are tried, tested and trusted treatments that have already undergone large-scale clinical trials. It already demonstrated efficacy in preclinical results and ‘patient zero’ case. In addition to MFA-370 showing positive preclinical results in metastatic urothelial bladder cancer, it has also eliminated prostate, breast and colorectal cancer cells in preclinical tests too. Currently, the drug is in Phase I/II stage of Clinical trial evaluation for the treatment of Metastatic Urothelial Carcinoma.

• XL 092: Exelixis

XL092 is a next-generation oral TKI that builds on our extensive experience with cabozantinib. XL092 also targets VEGF receptors, MET, TAM kinases and other kinases implicated in cancer’s growth and spread. In preclinical tumor models, XL092 showed excellent activity as a single agent and in combination with ICIs. XL092 also has an optimized pharmacokinetic profile aimed at facilitating adverse event management in the clinic. XL092 is the first new Exelixis-discovered compound to come out of the company’s reinitiated drug discovery activities, which entered phase 1 clinical development in 2019. Currently, the drug is in Phase I stage of Clinical trial evaluation for the treatment of Metastatic Urothelial Carcinoma.

• Lurbinectedin: PharmaMar

Lurbinectedin, also known as PM01183, or commercially where approved as Zepzelca® is an analogue of a similar natural compound ET-736 with characteristics that make it similar but different to its parent compounds. Lurbinectedin inhibits active transcription of protein-coding genes through binding to promoters and irreversibly stalling elongating RNA polymerase II on the DNA template, thereby leading to double-stranded DNA breaks and apoptosis. Currently, the drug is in Phase II stage of Clinical trial evaluation for the treatment of Metastatic Urothelial Carcinoma.

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

Metastatic Urothelial Carcinoma: Therapeutic Assessment

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

• Major Players in Metastatic Urothelial Carcinoma

There are approx. 40+ key companies which are developing the therapies for Metastatic Urothelial Carcinoma. The companies which have their Metastatic Urothelial Carcinoma drug candidates in the most advanced stage, i.e. phase II include, PharmaMar.

• Phases

DelveInsight’s report covers around 40+ 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 Urothelial Carcinoma pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Intra-articular
• Intraocular
• Intrathecal
• Intravenous
• Ophthalmic
• Oral
• Parenteral
• Subcutaneous
• Topical
• Transdermal
• Molecule Type

Products have been categorized under various Molecule types such as

• Oligonucleotide
• Peptide
• Small molecule
• Product Type

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

Metastatic Urothelial Carcinoma: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Metastatic Urothelial Carcinoma 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 Urothelial Carcinoma drugs.

Metastatic Urothelial Carcinoma Report Insights

• Metastatic Urothelial Carcinoma Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

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

Key Players

• PharmaMar
• Ectin Research AG
• Exelixis
• Eli Lilly and Company
• Merck Sharp & Dohme LLC
• Astellas Pharma Inc
• Seagen Inc.
• Shanghai Miracogen Inc.
• Advaxis, Inc.

Key Products

• MFA 370
• XL 092
• Lurbinectedin
• Ramucirumab
• AGS15E
• Ipilimumab
• MRG002
• ADXS-NEO

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