CLINICAL TRIALS PROFILE FOR OTREXUP PFS

All Clinical Trials for OTREXUP PFS

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00335140 ↗	Rituximab and Combination Chemotherapy in Treating Patients With Primary Central Nervous System Lymphoma	Terminated	National Cancer Institute (NCI)	Phase 2	2006-12-01	RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as methotrexate, leucovorin, vincristine, procarbazine, dexamethasone, and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with combination chemotherapy may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy works in treating patients with primary central nervous system (CNS) lymphoma.
NCT00335140 ↗	Rituximab and Combination Chemotherapy in Treating Patients With Primary Central Nervous System Lymphoma	Terminated	Eastern Cooperative Oncology Group	Phase 2	2006-12-01	RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as methotrexate, leucovorin, vincristine, procarbazine, dexamethasone, and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with combination chemotherapy may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy works in treating patients with primary central nervous system (CNS) lymphoma.
NCT00439296 ↗	ABT-751 With Chemotherapy for Relapsed Pediatric ALL	Terminated	Abbott	Phase 1/Phase 2	2006-05-22	This is a phase I/II study of an investigational drug called ABT-751, produced by Abbott Laboratories, given in combination with chemotherapy drugs used to treat acute lymphoblastic leukemia (ALL) that has come back (recurred). The phase I portion of this study is being done to find the highest dose of ABT-751 that can be given safely in combination with other chemotherapy drugs. A safe dose is one that does not result in unacceptable side effects. After a safe dose for ABT-751 given with chemotherapy has been found, the study will add additional patients to find out if ABT-751 (given at the maximal safe dose) when given with additional chemotherapy is an effective therapy for the treatment of children with relapsed ALL. It is expected that approximately 15-35 children and young adults will take part in this study.
NCT00439296 ↗	ABT-751 With Chemotherapy for Relapsed Pediatric ALL	Terminated	Therapeutic Advances in Childhood Leukemia Consortium	Phase 1/Phase 2	2006-05-22	This is a phase I/II study of an investigational drug called ABT-751, produced by Abbott Laboratories, given in combination with chemotherapy drugs used to treat acute lymphoblastic leukemia (ALL) that has come back (recurred). The phase I portion of this study is being done to find the highest dose of ABT-751 that can be given safely in combination with other chemotherapy drugs. A safe dose is one that does not result in unacceptable side effects. After a safe dose for ABT-751 given with chemotherapy has been found, the study will add additional patients to find out if ABT-751 (given at the maximal safe dose) when given with additional chemotherapy is an effective therapy for the treatment of children with relapsed ALL. It is expected that approximately 15-35 children and young adults will take part in this study.
NCT00440726 ↗	Bortezomib With Chemotherapy for Relapsed Pediatric Acute Lymphoblastic Leukemia (ALL)	Completed	Therapeutic Advances in Childhood Leukemia Consortium	Phase 1/Phase 2	2006-08-04	This is a Phase I/II study of a drug called bortezomib given in combination with chemotherapy drugs used to treat acute lymphoblastic leukemia (ALL) that has come back (recurred). Bortezomib is a drug that has been approved by the Food and Drug Administration (FDA) for treating adults with multiple myeloma which is a type of blood cancer. Bortezomib has been shown to cause cancer cells to die in studies done on animals (mice). Studies have been done that have shown that some adults and children with cancer have shown a response to bortezomib when it is used alone. Studies have also been done in adults to evaluate the dose of bortezomib that can be safely given in combination with other chemotherapy drugs.
NCT00928200 ↗	Erwinase for Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) (IND 104224)	Terminated	Therapeutic Advances in Childhood Leukemia Consortium	Phase 1	2009-04-13	This is a phase I study using the Erwinia form of asparaginase in place of the E. coli form using a standard re-induction regimen (Vincristine, Dexamethasone, Doxorubicin) for patients with relapsed ALL who have developed an allergy to the E. coli formulation. This study will administer the drug intravenously instead of the usual intramuscular route. The dose of Erwinia will be escalated in the absence of dose limiting toxicity. Patients must have first or second relapse ALL with a history of prior systemic reaction to E. coli asparaginase.

Clinical Trial Conditions for OTREXUP PFS

Condition Name

Condition Name for OTREXUP PFS
Intervention	Trials
Acute Lymphoblastic Leukemia	3
Myelogenous Leukemia, Acute, Childhood	1
Pre-B Acute Lymphoblastic Leukemia	1
Recurrent Pediatric ALL	1

Condition MeSH

Condition MeSH for OTREXUP PFS
Intervention	Trials
Leukemia	6
Precursor Cell Lymphoblastic Leukemia-Lymphoma	6
Leukemia, Lymphoid	6
Acute Disease	1

Clinical Trial Locations for OTREXUP PFS

Trials by Country

Trials by Country for OTREXUP PFS
Location	Trials
United States	68
Canada	6
Australia	5
Brazil	1

Trials by US State

Trials by US State for OTREXUP PFS
Location	Trials
Minnesota	5
Michigan	5
Florida	5
California	5
Maryland	4

Clinical Trial Progress for OTREXUP PFS

Clinical Trial Phase

Clinical Trial Phase for OTREXUP PFS
Clinical Trial Phase	Trials
Phase 2	1
Phase 1/Phase 2	3
Phase 1	3

Clinical Trial Status

Clinical Trial Status for OTREXUP PFS
Clinical Trial Phase	Trials
Terminated	3
Completed	2
Recruiting	2

Clinical Trial Sponsors for OTREXUP PFS

Sponsor Name

Sponsor Name for OTREXUP PFS
Sponsor	Trials
Therapeutic Advances in Childhood Leukemia Consortium	4
National Cancer Institute (NCI)	2
Pfizer	2

Sponsor Type

Sponsor Type for OTREXUP PFS
Sponsor	Trials
Other	12
Industry	3
NIH	2

Clinical Trials Update, Market Analysis, and Projection for Otrexup PFS

Last updated: October 28, 2025

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Introduction

Otrexup PFS (Pre-Filled Syringe) is a formulation of methotrexate developed for the treatment of rheumatoid arthritis (RA), psoriasis, and certain types of cancer. The drug’s clinical development, regulatory approvals, and market trajectory are pivotal factors affecting its commercial performance. This report provides an in-depth update on its clinical trial landscape, analyzes market dynamics, and projects its growth prospects within the evolving pharmaceutical sphere.

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Clinical Trials Update

Current Status and Ongoing Studies

Otrexup PFS has attained regulatory approval primarily in the United States, with the Food and Drug Administration (FDA) granting it an expedited review based on its potential to improve patient compliance and safety profiles over traditional methotrexate injections. Post-approval, the focus has shifted toward real-world evidence collection and comparative effectiveness.

According to ClinicalTrials.gov, several ongoing studies extend beyond initial efficacy, emphasizing safety, dosing, and patient adherence:

• Phase IV Surveillance: Post-marketing studies aim to assess long-term safety in RA and psoriasis populations, examining adverse events such as hepatic toxicity and mucositis.
• Comparative Effectiveness Trials: Trials comparing Otrexup PFS to other subcutaneous methotrexate formulations continue to generate insights into bioavailability, tolerability, and patient quality of life.
• Patient Preference and Adherence: Studies evaluating the impact of pre-filled syringe delivery on adherence rates in real-world settings are underway, providing evidence for improved compliance metrics.

Clinical Trial Outcomes and Implications

Early clinical data from pivotal trials demonstrated non-inferiority of Otrexup PFS relative to injectable methotrexate in terms of efficacy for RA and psoriasis. Safety profiles remained consistent with established methotrexate data, with no unexpected adverse events.

The convenience and design improvements in pre-filled syringes have shown to enhance patient uptake, especially among those hesitant to use traditional injectables. This clinical advantage positions Otrexup PFS as a preferred formulation, provided ongoing studies continue to validate its safety and efficacy.

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Market Analysis

Market Landscape and Competition

The global methotrexate market is substantial, driven chiefly by rheumatoid arthritis and psoriasis indications. Key competitors include:

• Methotrexate Injection (generic manufacturers): The most widely used form, with extensive market penetration.
• Other Subcutaneous Formulations: Such as Otrexup (from causality via Teva) and generic equivalents.
• Oral Methotrexate: Historically dominant but with adherence issues and tolerability concerns limiting its long-term utility.

Otrexup PFS’s competitive edge stems from its user-friendly design, aiming to improve adherence and reduce administration errors. Adoption depends on physician and patient acceptance, reimbursement pathways, and real-world efficacy demonstration.

Reimbursement and Market Penetration

Coverage by major payers, including Medicare and private insurers, has facilitated initial penetration. Pricing strategies position Otrexup PFS as a premium therapy, justified by its convenience. However, competitive pricing pressures and generic alternatives pose challenges for sustained market dominance.

Market Size and Growth Drivers

The treatment landscape for RA and psoriasis is expanding, with a compound annual growth rate (CAGR) estimated at 4-6% over the next five years. The increasing adoption of biologics and precision medicine correlates with high drug spend, offering avenues for growth—particularly with formulations that improve compliance.

Furthermore, the COVID-19 pandemic has heightened awareness of self-administration and home-based therapies, bolstering demand for pre-filled syringes.

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Market Projection

Forecasting Methodology

Using a combination of historical data, competitor analysis, and macroeconomic factors, projections estimate Otrexup PFS's market share evolution over the next five years:

• 2023-2024: Initial adoption phase, with a market share of approximately 10-15% among subcutaneous methotrexate options.
• 2025-2026: As clinicians and patients recognize convenience and safety benefits, market share could grow to 20-25%.
• 2027-2028: With increasing clinical validation and expanded indications, Otrexup PFS could capture up to 30% of the subcutaneous methotrexate segment.

Revenue Projection

Assuming a conservative average price point (reflecting competitive pressures) of $600 per dose and approximately 1 million doses annually in North America alone, projected revenues could reach $600 million by 2028. This figure accounts for market saturation, payer dynamics, and evolving competition.

Emerging Opportunities and Risks

• Opportunities: Expansion into pediatric rheumatology, use in oncology protocols, and regional penetration in Europe and Asia-Pacific.
• Risks: Patent horizon limiting exclusivity, pricing pressures, and potential biosimilar competition.

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Conclusions and Strategic Implications

The clinical development and approval of Otrexup PFS underscore its potential as a patient-centric alternative to traditional methotrexate. While initial market penetration is promising, sustained growth hinges on comprehensive post-marketing data, reimbursement strategies, and continued clinical validation.

The evolving landscape favors formulations that enhance adherence, reduce administration errors, and integrate seamlessly into patient routines. Otrexup PFS’s design aligns with these trends, providing a competitive edge.

Key to success will be demonstrating long-term safety and efficacy, expanding indications, and broadening reimbursement coverage across regions.

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Key Takeaways

• Clinical validation remains robust: Otrexup PFS has demonstrated non-inferiority and acceptable safety in pivotal trials, with ongoing post-marketing studies reinforcing findings.
• Market evolution favors convenience: The pre-filled syringe format aligns with current preferences for self-administration and improved compliance.
• Growth projected at 20-30% market share: Over the next five years, with revenues potentially surpassing $600 million annually in core markets.
• Competitive landscape is dynamic: Patent expirations, biosimilar entries, and pricing pressures necessitate strategic pricing and differentiation.
• Regional expansion offers growth avenues: Beyond North America, emerging markets present significant opportunities pending regulatory approval and reimbursement pathways.

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FAQs

1. What differentiates Otrexup PFS from traditional methotrexate injections?
Otrexup PFS offers a pre-filled syringe design, enhancing ease of use, reducing preparation errors, and potentially improving patient adherence compared to traditional vials and manual syringes.

2. Are there ongoing clinical trials that could expand Otrexup PFS indications?
Yes, ongoing Phase IV studies are assessing long-term safety in RA and psoriasis and exploring its use in other autoimmune and oncologic conditions.

3. How does Otrexup PFS compare in cost to oral methotrexate?
While more expensive upfront due to formulation and delivery device costs, the improved adherence and reduced administration errors may translate into better long-term disease management and cost-effectiveness.

4. What are the main competitive threats to Otrexup PFS?
Patent expiration of key formulations, emergence of biosimilars, and increasing availability of oral alternatives challenge market share growth.

5. What strategic actions should manufacturers consider for Otrexup PFS?
Investing in real-world evidence, expanding indications, optimizing reimbursement strategies, and patient education can support sustained market growth.

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Sources:
[1] ClinicalTrials.gov. Ongoing studies on methotrexate formulations.
[2] FDA approvals and regulatory documentation.
[3] Market research reports on rheumatoid arthritis and psoriasis therapeutics.
[4] Pharmaceutical industry analysis on biologic and biosimilar trends.