CLINICAL TRIALS PROFILE FOR M.V.I.-12 LYOPHILIZED

All Clinical Trials for M.v.i.-12 Lyophilized

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00024492 ↗	Study of Liposome Encapsulated Mitoxantrone (LEM) in Patients With Advanced Cancer	Completed	INSYS Therapeutics Inc	Phase 1	2001-08-01	Liposome entrapped mitoxantrone (LEM) is a mixture of commercially available mitoxantrone HCL (Novantrone) and a combination of lyophilized lipids. Mitoxantrone, the active agent in the investigational formulation, is a currently marketed chemotherapeutic agent. The rationale for development of liposomal formulations is primarily that of improving the safety profile of the drug, which may permit dose intensification and/or an increase in the cumulative dose that may be administered, resulting in enhanced efficacy. LEM will be given to patients with advanced solid tumors to determine the dose of drug these patients can tolerate. Patients will receive intravenous LEM every 21 days until the disease progresses or toxicity occurs requiring treatment discontinuation. Anti-tumor effects of LEM will be assessed and patients will be evaluated for safety and tolerability.
NCT00111956 ↗	Effects of Tumor Necrosis Factor (TNF)-Alpha Antagonism in Patients With Metabolic Syndrome	Completed	Massachusetts General Hospital	Phase 2/Phase 3	2004-04-01	Metabolic syndrome is associated with increased inflammatory cytokines and reduced adiponectin, that may be mediated in part by TNF production from abdominal fat. We reasoned that an anti-TNF agent would reduce C-reactive protein (CRP) and increase adiponectin, improving the inflammatory milieu associated with metabolic syndrome.
NCT00111956 ↗	Effects of Tumor Necrosis Factor (TNF)-Alpha Antagonism in Patients With Metabolic Syndrome	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 2/Phase 3	2004-04-01	Metabolic syndrome is associated with increased inflammatory cytokines and reduced adiponectin, that may be mediated in part by TNF production from abdominal fat. We reasoned that an anti-TNF agent would reduce C-reactive protein (CRP) and increase adiponectin, improving the inflammatory milieu associated with metabolic syndrome.

Clinical Trial Conditions for M.v.i.-12 Lyophilized

Condition Name

Condition Name for M.v.i.-12 Lyophilized
Intervention	Trials
Healthy	10
Aggressive Periodontitis	2
Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity	2

Condition MeSH

Condition MeSH for M.v.i.-12 Lyophilized
Intervention	Trials
Ulcer	6
Syndrome	5
Infections	4

Clinical Trial Locations for M.v.i.-12 Lyophilized

Trials by Country

Trials by Country for M.v.i.-12 Lyophilized
Location	Trials
United States	111
Italy	8
Germany	8
China	6
Canada	5

Trials by US State

Trials by US State for M.v.i.-12 Lyophilized
Location	Trials
Texas	10
Ohio	8
California	7
Massachusetts	7
Georgia	6

Clinical Trial Progress for M.v.i.-12 Lyophilized

Clinical Trial Phase

Clinical Trial Phase for M.v.i.-12 Lyophilized
Clinical Trial Phase	Trials
Phase 4	10
Phase 3	10
Phase 2/Phase 3	6

Clinical Trial Status

Clinical Trial Status for M.v.i.-12 Lyophilized
Clinical Trial Phase	Trials
Completed	47
Not yet recruiting	14
Recruiting	10

Clinical Trial Sponsors for M.v.i.-12 Lyophilized

Sponsor Name

Sponsor Name for M.v.i.-12 Lyophilized
Sponsor	Trials
The University of Texas Health Science Center, Houston	6
Ohio State University Comprehensive Cancer Center	4
GlaxoSmithKline	3

Sponsor Type

Sponsor Type for M.v.i.-12 Lyophilized
Sponsor	Trials
Other	85
Industry	42
NIH	1

M.V.I.-12 Lyophilized: Clinical Trials, Market Analysis, and Projections

Introduction

M.V.I.-12 Lyophilized, a multivitamin infusion formulation, is crucial in clinical settings where parenteral nutrition is necessary. This article delves into the clinical trials, market analysis, and future projections for this drug.

Clinical Indications and Usage

M.V.I.-12 Lyophilized is indicated for daily multivitamin maintenance in adults and children aged 11 and above who are receiving parenteral nutrition. It is particularly useful in situations such as surgery, extensive burns, fractures, severe infectious diseases, and comatose states, where the body's metabolic demands are significantly altered[1].

Composition and Administration

The formulation includes a combination of fat-soluble and water-soluble vitamins, with vitamins A, D, and E solubilized in an aqueous medium using polysorbate 80. This allows for intravenous administration. The vial contains biotin, folic acid, vitamin B12, and other essential vitamins. It must be aseptically transferred to the infusion fluid and diluted in at least 500 mL of intravenous solution before administration[1].

Clinical Trials and Efficacy

Clinical testing has shown that M.V.I.-12 Lyophilized helps maintain adequate levels of vitamins in patients who cannot receive nutrition through the gastrointestinal tract. However, some patients may not maintain adequate levels of certain vitamins, necessitating periodic monitoring to prevent deficiencies or excesses[1].

Market Analysis

Global Lyophilized Injectable Market

The global lyophilized injectable market, which includes products like M.V.I.-12 Lyophilized, is projected to grow significantly. By 2028, the market is expected to reach $4 billion from $2.71 billion in 2021, growing at a CAGR of 5.8%[2].

Segmentation and Growth Drivers

The market is segmented by type of packaging, delivery, indication, and end user. The single-use vials segment currently holds the largest market share, but specialty packaging is expected to register the highest CAGR during the forecast period. The prefilled diluent syringes segment also dominates in terms of delivery, with metabolic and oncology conditions being the largest indication segment[2].

Key Growth Factors

• Increasing Demand for Contract Research Manufacturing Services: The need for high-quality, stable products has driven the demand for lyophilized injectables, particularly in the pharmaceutical and diagnostic sectors[2].
• Rising Pharmaceutical Production: The COVID-19 pandemic has accelerated pharmaceutical production, including lyophilized injectables, due to their stability and prolonged shelf life[2].
• Expansion of Biologics Pipeline: The growing pipeline of biologic drugs, which often require lyophilization, is another significant growth factor[3].

Projections and Future Trends

Market Size and Growth

The lyophilized injectable drugs market is expected to grow to $4.48 billion by 2028 at a CAGR of 3.3%. This growth is driven by factors such as the rise in personalized medicine, expansion of biologics pipeline, and increased focus on patient compliance[3].

Innovations and New Product Launches

Innovations in lyophilized combination therapies and the expansion of lyophilized vaccines are expected to drive market growth. Recent examples include the approval and launch of remdesivir (lyophilized powder for injection) for COVID-19 treatment by companies like Mylan N.V. and Cipla Ltd.[5].

Regulatory Emphasis

Regulatory bodies are emphasizing the validation of the lyophilization process, which is expected to further standardize and grow the market. The integration of quality-by-design (QbD) principles is also anticipated to enhance product quality and stability[3].

Challenges and Restraints

Despite the growth potential, the lyophilized injectable drugs market faces challenges such as:

• High Cost of Processing: The lyophilization process is costly, which can hamper market growth.
• Lack of Awareness: Limited awareness about the benefits and applications of lyophilized injectable drugs in certain health conditions can also restrain market expansion[5].

Key Takeaways

• M.V.I.-12 Lyophilized is a critical multivitamin infusion used in parenteral nutrition.
• The global lyophilized injectable market is growing due to increasing demand for contract research manufacturing services and rising pharmaceutical production.
• Innovations in lyophilized combination therapies and vaccines, along with regulatory emphasis on process validation, are driving market growth.
• Despite growth potential, the market faces challenges such as high processing costs and limited awareness.

FAQs

What is M.V.I.-12 Lyophilized used for?

M.V.I.-12 Lyophilized is used as a daily multivitamin maintenance dosage for adults and children aged 11 and above receiving parenteral nutrition, especially in situations like surgery, burns, and severe infectious diseases.

What are the key growth drivers for the lyophilized injectable market?

Key growth drivers include increasing demand for contract research manufacturing services, rising pharmaceutical production due to the COVID-19 pandemic, and the expansion of biologics pipeline.

What are the challenges facing the lyophilized injectable drugs market?

Challenges include the high cost of the lyophilization process and limited awareness about the benefits and applications of lyophilized injectable drugs in certain health conditions.

How is the lyophilized injectable market segmented?

The market is segmented by type of packaging, delivery, indication, and end user. Single-use vials and prefilled diluent syringes are dominant segments, with metabolic and oncology conditions being the largest indication segment.

What are some recent innovations in the lyophilized injectable market?

Recent innovations include the approval and launch of remdesivir (lyophilized powder for injection) for COVID-19 treatment and the integration of quality-by-design (QbD) principles to enhance product quality and stability.

Sources

1. FDA Label for M.V.I.-12: Access Data FDA, MVI – 12®.
2. Global Lyophilized Injectable Market Report: GlobeNewswire, Lyophilized Injectable Market Share to hit $4Bn, Globally.
3. Global Lyophilized Injectable Drugs Market Report: The Business Research Company, Global Lyophilized Injectable Drugs Market Report 2024.
4. Vitamin E - PharmaKB: PharmaKB, Vitamin e - PharmaKB.
5. Lyophilized Injectable Drugs Market Growth Analysis: Allied Market Research, Lyophilized Injectable Drugs Market Growth Analysis by 2027.