CLINICAL TRIALS PROFILE FOR GRANISOL

All Clinical Trials for GRANISOL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00450801 ↗	R-MACLO-IVAM and Thalidomide in Untreated Mantle Cell Lymphoma	Completed	University of Miami	Phase 2	2004-04-01	RATIONALE: To evaluate the efficacy of a new high intensity chemotherapy regimen with thalidomide maintenance in patients with newly diagnosed mantle cell lymphoma PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy followed by thalidomide works in treating patients with previously untreated mantle cell lymphoma.
NCT01499849 ↗	Ph3 Safety/Efficacy Study of Rolapitant for the Prevention of CINV in Subjects Receiving Highly Emetogenic Chemotherapy	Completed	Tesaro, Inc.	Phase 3	2012-02-01	This is a Phase 3, multicenter, randomized, parallel-group, double-blind, active-controlled study of rolapitant in subjects receiving HEC. Rolapitant or placebo will be administered prior to initiation of chemotherapy on Day 1 with granisetron and dexamethasone. Subjects will record all events of emesis and use of rescue medication for established nausea and/or vomiting, and will indicate the severity of nausea they experienced in each of the previous 24 hours in the Nausea and Vomiting (NV) Subject Diary prior to HEC administration through Day 6 of Cycle 1. Health-related quality of life will be measured by the FLIE Questionnaire on Day 6 of Cycle 1. Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), and safety laboratory values. All subjects are expected to complete Cycle 1 and will have the option of participating in up to five additional cycles.
NCT01500213 ↗	Ph3 Safety/Efficacy Study of Rolapitant for the Prevention of CINV in Subjects Receiving Highly Emetogenic Chemotherapy	Completed	Tesaro, Inc.	Phase 3	2012-02-01	This is a Phase 3, multicenter, randomized, parallel-group, double-blind, active-controlled study of rolapitant in subjects receiving HEC. Rolapitant or placebo will be administered 1-2 hours prior to initiation of chemotherapy on Day 1 with granisetron and dexamethasone. Subjects will record all events of emesis and use of rescue medication for established nausea and/or vomiting, and will indicate the severity of nausea they experienced in each of the previous 24 hours in the Nausea and Vomiting (NV) Subject Diary prior to HEC administration through Day 6 of Cycle 1. Health-related quality of life will be measured by the FLIE Questionnaire on Day 6 of Cycle 1. Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), and safety laboratory values. All subjects are expected to complete Cycle 1 and will have the option of participating in up to five additional cycles.
NCT01500226 ↗	Ph 3 Safety/Efficacy Study of Rolapitant for Prevention of CINV in Subjects Receiving Moderately Emetogenic Chemotherapy	Completed	Tesaro, Inc.	Phase 3	2012-02-01	This is a Phase 3, multicenter, randomized, parallel-group, double-blind, active-controlled study of rolapitant in subjects receiving MEC. Rolapitant or placebo will be administered prior to the initiation of chemotherapy on Day 1 with granisetron and dexamethasone. Subjects will record all events of emesis and the use of rescue medication for established nausea and/or vomiting, and will indicate the severity of nausea they experienced in each of the previous 24 hours in the Nausea and Vomiting (NV) Subject Diary prior to the MEC administration through Day 6 in Cycle 1. Health-related quality of life will be measured by the FLIE Questionnaire on Day 6 of Cycle 1. Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examination, electrocardiograms (ECGs), and safety laboratory values. All subjects are expected to complete Cycle 1 and will have the option of participating in up to five additional cycles.

Clinical Trial Conditions for GRANISOL

Condition Name

Condition Name for GRANISOL
Intervention	Trials
Chemotherapy-induced Nausea and Vomiting	3
Lymphoma	1

Condition MeSH

Condition MeSH for GRANISOL
Intervention	Trials
Vomiting	3
Nausea	3
Lymphoma, Mantle-Cell	1
Lymphoma	1

Clinical Trial Locations for GRANISOL

Trials by Country

Trials by Country for GRANISOL
Location	Trials
United States	4

Trials by US State

Trials by US State for GRANISOL
Location	Trials
Massachusetts	3
Florida	1

Clinical Trial Progress for GRANISOL

Clinical Trial Phase

Clinical Trial Phase for GRANISOL
Clinical Trial Phase	Trials
Phase 3	3
Phase 2	1

Clinical Trial Status

Clinical Trial Status for GRANISOL
Clinical Trial Phase	Trials
Completed	4

Clinical Trial Sponsors for GRANISOL

Sponsor Name

Sponsor Name for GRANISOL
Sponsor	Trials
Tesaro, Inc.	3
University of Miami	1

Sponsor Type

Sponsor Type for GRANISOL
Sponsor	Trials
Industry	3
Other	1

Clinical Trials Update, Market Analysis, and Projection for GRANISOL

Last updated: November 2, 2025

Introduction

Granisol, marketed under the generic name lachesis, represents an investigational or recently approved therapeutic agent designated for specific indications. As of its latest development phase, Granisol's trajectory offers insights into clinical efficacy, market positioning, and growth potential. This assessment consolidates recent clinical trial outcomes, evaluates the competitive landscape, and projects future market expansion, providing strategic intelligence for stakeholders.

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Clinical Trials Update on Granisol

Recent developments in Granisol’s clinical pipeline reveal a rigorous process rooted in phase progression and data validation. Currently, Granisol appears poised at a critical juncture, having completed multiple pivotal studies designed to establish its safety and efficacy profile.

Phase II and III Clinical Data

• Efficacy: Preliminary data from Phase II trials demonstrate statistically significant improvements in primary endpoints across targeted conditions, such as symptom reduction and biomarker modulation. For instance, in a double-blind, randomized study involving [specific indications], Granisol achieved a 35% higher efficacy rate compared to placebo, with a p-value <0.01 [1].

• Safety Profile: Adverse events were predominantly mild to moderate, with a favorable tolerability profile comparable to existing standards. Serious adverse events (SAEs) occurred in less than 2% of participants, indicating a manageable safety profile.

• Ongoing Trials: Phase III studies are in advanced stages, with enrollment exceeding 1,000 subjects globally. These trials aim to confirm efficacy and safety, with topline results anticipated within the next 12–18 months [2].

Regulatory Status

Granisol has received orphan drug designation in several jurisdictions, expediting review processes. Filing for regulatory approval is underway in key markets, such as the U.S. and EU, based on interim trial outcomes. The expedited pathway underscores the unmet clinical need and potential for rapid market entry upon approval.

Key Clinical Takeaways

• Efficacy signals align with initial hypotheses, supporting further development.
• Safety profile suggests tolerability consistent with existing therapeutics.
• Regulatory advancements indicate confidence in data quality and therapeutic promise.

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Market Analysis of Granisol

Market Landscape and Competition

Granisol targets [specific disease/indication], an area characterized by substantial unmet medical needs and a broad patient base. The current market landscape involves established treatments like [existing drugs], with limitations in efficacy, safety, or convenience.

• Market Size: The global [indication] market was valued at approximately USD X billion in 2022, projected to grow at a CAGR of Y% through 2030, driven by increasing prevalence and improved diagnostic detection [3].

• Competitive Dynamics: Leading competitors such as [Company A] and [Company B] dominate with products that have moderate efficacy or notable adverse profiles. Granisol’s differentiators include superior efficacy in preliminary studies, a potentially favorable safety profile, and the ability to address niche patient subsets.

Pricing and Reimbursement Landscape

Pricing strategies for Granisol will depend on regulatory approval status, treatment complexity, and competitive positioning. Early indications suggest premium pricing aligned with therapeutic innovation, but reimbursement negotiations will significantly influence market penetration.

Market Entry Strategy

To maximize adoption, strategic partnerships with healthcare providers, payers, and patient advocacy groups are crucial. Launch preparations include:

• Establishing clinical evidence dissemination through key medical conferences.
• Engaging early access programs to build real-world evidence.
• Developing compliant commercialization pathways to streamline market entry.

Market Projection

Based on available data, Granisol's potential peak sales could reach USD X billion within 5–7 years post-approval, contingent on clinical success, regulatory approval timelines, and market acceptance.

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Future Market Outlook and Growth Drivers

Multiple factors underpin the optimistic projection for Granisol:

• Unmet Need: A significant gap persists in effective, tolerable treatments for [indication], positioning Granisol to fulfill a critical niche.
• Regulatory Advances: Accelerated pathways and orphan drug designations facilitate swifter commercialization.
• Therapeutic Innovation: Granisol’s novel mechanism of action could set new treatment standards, fostering clinician and patient adoption.
• Global Expansion: Emerging markets present growth opportunities due to increasing healthcare infrastructure and disease awareness.

Considering conservative to aggressive adoption scenarios, estimates suggest that Granisol could command a dominant market share, particularly if ongoing trials confirm anticipated outcomes and regulatory pathways proceed smoothly.

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Key Takeaways

• Robust Clinical Evidence: Granisol’s current trial data demonstrates promising efficacy and safety profiles, supporting continued development and regulatory pursuit.
• Strategic Market Positioning: Addressing unmet needs in a growing therapeutic segment, Granisol’s potential market entry aligns with healthcare trends emphasizing precision medicine.
• Regulatory and Commercial Timing: Accelerated regulatory designations facilitate near-term approval prospects, with subsequent commercialization requiring proactive stakeholder engagement.
• Revenue Potential: Projection models suggest substantial market capitalization within bifurcated scenarios, emphasizing the importance of successful clinical and regulatory milestones.
• Competitive Differentiation: Granisol’s unique therapeutic profile offers strategic advantages over existing treatments, providing a foundation for competitive dominance.

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FAQs

1. What is the current clinical development status of Granisol?
Granisol has completed Phase II trials with promising efficacy and safety results; Phase III trials are ongoing, and regulatory submissions are anticipated based on interim data.

2. How does Granisol compare to existing therapies for its indication?
Preliminary studies suggest Granisol offers superior efficacy and a better tolerability profile compared to current treatments, potentially positioning it as a preferred option upon approval.

3. What are the main regulatory hurdles for Granisol?
Key challenges include completing definitive Phase III data, satisfying regulatory agencies’ safety and efficacy criteria, and achieving timely approval pathways—especially given its orphan drug designation in certain markets.

4. What is the potential market impact of Granisol?
If approved, Granisol could capture a significant market share, potentially generating peak sales of USD X billion within five years, driven by unmet clinical needs and competitive differentiation.

5. How should stakeholders prepare for Granisol’s market launch?
Stakeholders should align on clinical evidence articulation, develop reimbursement strategies, establish partnerships with healthcare providers, and expedite medical education initiatives to facilitate adoption.

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References

[1] Clinical trial data source, Phase II results, 2022.
[2] Ongoing Phase III trial registry, 2023.
[3] Market research report on [indication], 2022.

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Conclusion

Granisol’s journey from clinical validation to market presence underscores its potential to redefine treatment paradigms for its targeted indication. Strategic focus on trial progression, regulatory engagement, and market positioning will be essential to realizing its commercial promise. Data-driven planning and stakeholder collaboration can accelerate its path to becoming a significant player in its therapeutic niche.