CLINICAL TRIALS PROFILE FOR VESANOID

All Clinical Trials for Vesanoid

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00005825 ↗	Combination Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer	Unknown status	Raghu Nandan, M.D., Inc	Phase 2	1998-09-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have stage IIIB or stage IV non-small cell lung cancer.
NCT00006220 ↗	Arsenic Trioxide With or Without Tretinoin in Treating Patients With Hematologic Cancer That Has Not Responded to Previous Therapy	Terminated	National Cancer Institute (NCI)	Phase 1/Phase 2	1999-06-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Tretinoin may help hematologic cancer cells develop into normal white blood cells. PURPOSE: Phase I/II trial to study the effectiveness of arsenic trioxide with or without tretinoin in treating patients who have hematologic cancer that has not responded to previous therapy.
NCT00006220 ↗	Arsenic Trioxide With or Without Tretinoin in Treating Patients With Hematologic Cancer That Has Not Responded to Previous Therapy	Terminated	Washington University School of Medicine	Phase 1/Phase 2	1999-06-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Tretinoin may help hematologic cancer cells develop into normal white blood cells. PURPOSE: Phase I/II trial to study the effectiveness of arsenic trioxide with or without tretinoin in treating patients who have hematologic cancer that has not responded to previous therapy.
NCT00326170 ↗	Phase II 5-Azacytidine Plus VPA Plus ATRA	Completed	Celgene Corporation	Phase 2	2005-07-01	5-aza is a chemotherapy drug with activity in leukemia and myelodysplastic syndromes (MDS). Researchers hope that valproic acid (VPA) and all-trans retinoic acid (ATRA)will increase the effects of 5-aza. The goal of this clinical research study is to find the highest safe dose of valproic acid (VPA) that can be given in combination with 5-azacytidine (5-aza) and all-trans retinoic acid (ATRA) in the treatment of AML and MDS. The safety and effectiveness of this combination therapy will also be studied. Additional blood and bone marrow samples will be requested. These samples will be used to evaluate the effect of the treatment on leukemic cells. In addition, any leftover blood and bone marrow samples that are collected at the start of the study and during the regularly scheduled evaluations to be sent for research studies. The research studies will examine changes in the blood and bone marrow cells that might help explain the causes of leukemia and MDS and how the combination of 5-aza, VPA, and ATRA works.
NCT00326170 ↗	Phase II 5-Azacytidine Plus VPA Plus ATRA	Completed	M.D. Anderson Cancer Center	Phase 2	2005-07-01	5-aza is a chemotherapy drug with activity in leukemia and myelodysplastic syndromes (MDS). Researchers hope that valproic acid (VPA) and all-trans retinoic acid (ATRA)will increase the effects of 5-aza. The goal of this clinical research study is to find the highest safe dose of valproic acid (VPA) that can be given in combination with 5-azacytidine (5-aza) and all-trans retinoic acid (ATRA) in the treatment of AML and MDS. The safety and effectiveness of this combination therapy will also be studied. Additional blood and bone marrow samples will be requested. These samples will be used to evaluate the effect of the treatment on leukemic cells. In addition, any leftover blood and bone marrow samples that are collected at the start of the study and during the regularly scheduled evaluations to be sent for research studies. The research studies will examine changes in the blood and bone marrow cells that might help explain the causes of leukemia and MDS and how the combination of 5-aza, VPA, and ATRA works.
NCT00339196 ↗	5-azacytidine Valproic Acid and ATRA in AML and High Risk MDS	Completed	Assistance Publique - Hôpitaux de Paris	Phase 2	2006-07-01	MULTICENTERS. Uncontrolled and open phase II study. Evaluation of the effectiveness of a treatment associating 5 Azacytidine,Valproic acid ,Retinoic Acid at subjects-reached of syndromes myelodysplasia and acute MYELOID leukaemia Hematological response at 6 months Uncontrolled prospective cohort.

Clinical Trial Conditions for Vesanoid

Condition Name

Condition Name for Vesanoid
Intervention	Trials
Acute Myelogenous Leukemia	3
Myelodysplastic Syndrome	3
Leukemia	2
Acute Myeloid Leukemia	2

Condition MeSH

Condition MeSH for Vesanoid
Intervention	Trials
Leukemia	10
Leukemia, Myeloid, Acute	7
Myelodysplastic Syndromes	6
Preleukemia	6

Clinical Trial Locations for Vesanoid

Trials by Country

Trials by Country for Vesanoid
Location	Trials
United States	69
Canada	6
Australia	6
New Zealand	2
Germany	1

Trials by US State

Trials by US State for Vesanoid
Location	Trials
Texas	6
California	3
Colorado	3
Ohio	3
Oregon	3

Clinical Trial Progress for Vesanoid

Clinical Trial Phase

Clinical Trial Phase for Vesanoid
Clinical Trial Phase	Trials
Phase 3	2
Phase 2	10
Phase 1/Phase 2	4

Clinical Trial Status

Clinical Trial Status for Vesanoid
Clinical Trial Phase	Trials
Completed	8
Recruiting	5
Active, not recruiting	3

Clinical Trial Sponsors for Vesanoid

Sponsor Name

Sponsor Name for Vesanoid
Sponsor	Trials
Celgene Corporation	4
M.D. Anderson Cancer Center	4
National Cancer Institute (NCI)	3

Sponsor Type

Sponsor Type for Vesanoid
Sponsor	Trials
Other	36
Industry	9
NIH	4

Vesanoid (Tretinoin): Clinical Trials Update, Market Analysis, and Projections

Introduction to Vesanoid (Tretinoin)

Vesanoid, also known as tretinoin, is a retinoid that has been approved for the treatment of acute promyelocytic leukemia (APL). It is the first retinoid to receive a cancer indication and plays a crucial role in the induction of remission in APL patients[4].

Clinical Trials Update

Ongoing and Terminated Trials

Several clinical trials involving Vesanoid are currently underway or have recently concluded. Here are some key updates:

• Terminated Trial: A Phase 1 trial conducted by Taiho Oncology, Inc. was terminated due to the changing treatment landscape, difficulty in enrolling eligible participants, and little likelihood of providing meaningful clinical benefit[1].
• Active Trials: Trials such as the STARPAC2 study, which combines Vesanoid with other drugs for pancreatic cancer, are active but not recruiting new participants. This trial has seen changes in its phase classification and completion dates[1].
• Recruiting Trials: The LySATRA trial, which involves Vesanoid in patients with oligo-metastatic solid cancer, is currently recruiting participants[1].
• Combination Therapies: Vesanoid is being tested in combination with other drugs like nivolumab for pancreatic cancer and pembrolizumab for advanced melanoma. These trials are either active or have recently completed enrollment[1].

Challenges and Outcomes

Clinical trials involving Vesanoid often face challenges such as difficulty in enrolling participants and the need to adapt to changing treatment landscapes. Despite these challenges, Vesanoid has shown significant efficacy in treating APL. For instance, in clinical trials, Vesanoid-treated patients have achieved complete remission rates ranging from 50% to 80%, with median survival times between 5.8 and 10.8 months[4].

Adverse Effects and Management

Vesanoid treatment can lead to serious adverse effects, including retinoic acid-APL (RA-APL) syndrome and rapidly evolving leukocytosis. High-dose steroids are often used to manage RA-APL syndrome, and full-dose chemotherapy may be added to the Vesanoid regimen in cases of leukocytosis[4].

Market Analysis

Market Size and Growth

The global market for Vesanoid, which falls under the broader category of tretinoin drugs, is expected to grow significantly over the next few years.

• Current Market Size: The global tretinoin drugs market was estimated to be worth US$ 275 million in 2023[5].
• Projected Growth: This market is forecasted to reach US$ 359.7 million by 2030, growing at a CAGR of 4.2% from 2024 to 2030[5].

Segmentation and Application

The Vesanoid market is segmented by type and application:

• Type: Vesanoid is available in oral and injection forms[2].
• Application: It is primarily used in hospitals and pharmacies[2].

Competitive Landscape

The market for Vesanoid is dominated by key players such as Roche and CHEPLAPHARM. The competitive landscape is analyzed using tools like Porter's Five Forces and PESTLE analysis, which help in understanding the market dynamics and strategies of the major players[2].

Regional Analysis

The global Vesanoid market is analyzed by region, including North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa. This regional analysis provides insights into sales, revenue, and growth trends in different parts of the world[2].

Projections and Future Outlook

Market Growth Drivers

Several factors are driving the growth of the Vesanoid market:

• Increasing Prevalence of APL: The rising incidence of acute promyelocytic leukemia is a key driver for the demand of Vesanoid.
• Advancements in Treatment: The development of combination therapies involving Vesanoid is expected to enhance its efficacy and expand its use in various cancer treatments.
• Globalization of Clinical Trials: The increasing globalization of clinical trials is facilitating the access and adoption of Vesanoid in different regions[3].

Challenges and Opportunities

Despite the positive outlook, the market faces challenges such as the teratogenic effects of Vesanoid, which necessitate strict contraceptive measures for women of childbearing potential. However, the ongoing research and development in combination therapies offer significant opportunities for market growth[4].

Key Takeaways

• Clinical Trials: Vesanoid is involved in various clinical trials, including those for pancreatic cancer, melanoma, and other solid cancers.
• Market Growth: The global tretinoin drugs market, including Vesanoid, is projected to grow at a CAGR of 4.2% from 2024 to 2030.
• Efficacy and Safety: Vesanoid has shown significant efficacy in treating APL but requires careful management of adverse effects.
• Market Segmentation: The market is segmented by type (oral and injection) and application (hospitals and pharmacies).
• Competitive Landscape: Key players like Roche and CHEPLAPHARM dominate the market, with a competitive landscape analyzed through Porter's Five Forces and PESTLE analysis.

FAQs

What is Vesanoid used for?

Vesanoid (tretinoin) is used for the induction of remission in patients with acute promyelocytic leukemia (APL)[4].

What are the common adverse effects of Vesanoid?

Common adverse effects include retinoic acid-APL (RA-APL) syndrome and rapidly evolving leukocytosis. High-dose steroids and full-dose chemotherapy may be used to manage these effects[4].

What is the projected market size of tretinoin drugs by 2030?

The global tretinoin drugs market, including Vesanoid, is forecasted to reach US$ 359.7 million by 2030[5].

Which companies are major players in the Vesanoid market?

Key players in the Vesanoid market include Roche and CHEPLAPHARM[2].

What are the different forms in which Vesanoid is available?

Vesanoid is available in oral and injection forms[2].

How does the globalization of clinical trials impact the Vesanoid market?

The globalization of clinical trials facilitates the access and adoption of Vesanoid in different regions, contributing to market growth[3].

Sources

1. LARVOL VERI: News - Vesanoid (tretinoin) - LARVOL VERI
2. OpenPR: Vesanoid Market Report- Top Manufacturers, Future Growth Outlook, Trends | Roche
3. Grand View Research: Clinical Trials Market Size, Share And Growth Report, 2030
4. Cancer Network: Vesanoid, First Retinoid to Receive a Cancer Indication,Is Approved ...
5. Valuates Reports: Tretinoin Drugs - Market, Report Size, Worth, Revenue, Growth ...