CLINICAL TRIALS PROFILE FOR LEVOLEUCOVORIN

All Clinical Trials for LEVOLEUCOVORIN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01290783 ↗	Trial of FOLF(HA)Iri Versus FOLFIRI in mCRC	Unknown status	Alchemia Oncology	Phase 3	2011-12-01	Trial design: - Phase III, FOLFIRI versus FOLF(HA)iri (the FOLFIRI regimen with "Hyaluronic acid-Irinotecan" or "HA-Irinotecan") regimen. - Patients with mCRC (metastatic colorectal cancer), 2nd/3rd line irinotecan naïve. - Randomized 1:1, double-blinded, multi-centre, multi-national (Australia, Bulgaria, Poland, Serbia, Russia, Ukraine and the United Kingdom). - Dosing regimen: - Irinotecan (180 mg/m2) or HA-Irinotecan (180 mg/m2), IV, over 90 minutes, day 1 (in patients > 75 years of age, the irinotecan and HA-Irinotecan dose in must be reduced to 150 mg/m2). - Leucovorin, 400 mg/m2, or levoleucovorin, 200 mg/m2, IV over 90 minutes with irinotecan. - 5-fluorouracil (5-FU), 400 mg/m2 IV bolus day 1, then 1200 mg/m2/day x 2 days (total 2400 mg/m2 over 46-48 hours) continuous infusion. - Repeat every 2 weeks for 8 months. - Patient accrual over approximately 12-14 months. - Monitoring to 18 months post-randomization. - 390 patients. - Progression Free Survival (PFS) primary endpoint. - Safety analysis on the initial 20 patients.
NCT01611857 ↗	Phase I/II Trial of Tivantinib With FOLFOX for the Treatment of Advanced Solid Tumors and Previously Untreated Metastatic Adenocarcinoma of the Distal Esophagus, Gastroesophageal Junction or Stomach	Completed	Daiichi Sankyo Inc.	Phase 1/Phase 2	2012-07-01	This study is a Phase I/II trial of Tivantinib plus FOLFOX for the treatment of patients with advanced solid tumors. In Phase I the Maximum Tolerated Dose (MTD) will be determined; in Phase II patients with first-line metastatic GE cancer will be treated at the MTD. It is hypothesized that the response rate (RR) will be improved from 45% to at least 65% under this regimen.
NCT01611857 ↗	Phase I/II Trial of Tivantinib With FOLFOX for the Treatment of Advanced Solid Tumors and Previously Untreated Metastatic Adenocarcinoma of the Distal Esophagus, Gastroesophageal Junction or Stomach	Completed	Daiichi Sankyo, Inc.	Phase 1/Phase 2	2012-07-01	This study is a Phase I/II trial of Tivantinib plus FOLFOX for the treatment of patients with advanced solid tumors. In Phase I the Maximum Tolerated Dose (MTD) will be determined; in Phase II patients with first-line metastatic GE cancer will be treated at the MTD. It is hypothesized that the response rate (RR) will be improved from 45% to at least 65% under this regimen.
NCT01611857 ↗	Phase I/II Trial of Tivantinib With FOLFOX for the Treatment of Advanced Solid Tumors and Previously Untreated Metastatic Adenocarcinoma of the Distal Esophagus, Gastroesophageal Junction or Stomach	Completed	SCRI Development Innovations, LLC	Phase 1/Phase 2	2012-07-01	This study is a Phase I/II trial of Tivantinib plus FOLFOX for the treatment of patients with advanced solid tumors. In Phase I the Maximum Tolerated Dose (MTD) will be determined; in Phase II patients with first-line metastatic GE cancer will be treated at the MTD. It is hypothesized that the response rate (RR) will be improved from 45% to at least 65% under this regimen.
NCT01681472 ↗	PK/PD Investigation of Modufolin (Arfolitixorin) in Plasma, Tumor and Adjacent Mucosa Adjacent Mucosa in Patients With Colon Cancer	Completed	Isofol Medical AB	Phase 1/Phase 2	2012-09-01	The purpose of this study is to compare the concentration of four different metabolites in the tumor, in adjacent mucosa and in plasma in patients with colon cancer receiving two different doses of Modufolin (arfolitixorin) and Levoleucovorin (Isovorin®), respectively (60 and 200 mg/m2).
NCT01789723 ↗	Phase 1 Study of Fusilev to Prevent or Reduce Mucositis in Patients With Non-Hodgkin's Lymphoma Receiving Folotyn	Withdrawn	Acrotech Biopharma LLC	Phase 1	2013-03-01	The purpose of this study is determine the optimal dose and schedule of Fusilev to prevent or reduce Mucositis in patients with Non-Hodgkin's Lymphoma receiving Folotyn treatment.

Clinical Trial Conditions for LEVOLEUCOVORIN

Condition Name

Condition Name for LEVOLEUCOVORIN
Intervention	Trials
Colorectal Neoplasms	5
Colorectal Cancer	3
Metastatic Colorectal Cancer	2
Colonic Neoplasms	2

Condition MeSH

Condition MeSH for LEVOLEUCOVORIN
Intervention	Trials
Colorectal Neoplasms	9
Esophageal Squamous Cell Carcinoma	4
Esophageal Neoplasms	4
Neoplasms	3

Clinical Trial Locations for LEVOLEUCOVORIN

Trials by Country

Trials by Country for LEVOLEUCOVORIN
Location	Trials
United States	125
China	25
France	17
Japan	15
United Kingdom	10

Trials by US State

Trials by US State for LEVOLEUCOVORIN
Location	Trials
Pennsylvania	6
New York	6
Michigan	6
California	6
Washington	6

Clinical Trial Progress for LEVOLEUCOVORIN

Clinical Trial Phase

Clinical Trial Phase for LEVOLEUCOVORIN
Clinical Trial Phase	Trials
PHASE3	2
PHASE2	3
PHASE1	2

Clinical Trial Status

Clinical Trial Status for LEVOLEUCOVORIN
Clinical Trial Phase	Trials
Recruiting	8
Withdrawn	3
Completed	2

Clinical Trial Sponsors for LEVOLEUCOVORIN

Sponsor Name

Sponsor Name for LEVOLEUCOVORIN
Sponsor	Trials
Merck Sharp & Dohme Corp.	3
Acrotech Biopharma LLC	2
Spectrum Pharmaceuticals, Inc	2

Sponsor Type

Sponsor Type for LEVOLEUCOVORIN
Sponsor	Trials
Industry	20
Other	8
NIH	2

Levoleucovorin clinical trials update, market analysis, and future revenue projection

Last updated: July 28, 2026

What is levoleucovorin and where is it used clinically?

Levoleucovorin is the pharmacologically active (L-) enantiomer of leucovorin used to modulate folate metabolism in combination chemotherapy. The most common clinical positioning is as “folinic acid” rescue/sensitization in regimens that include fluoropyrimidines, including 5-fluorouracil (5-FU) and capecitabine, and in protocols that require leucovorin-dependent biochemical effects.

Clinical use depends on the local regulatory labeling. In practice, levoleucovorin is used to support dosing schedules where leucovorin is specified as a required component of the regimen, typically to enhance efficacy and reduce toxicity associated with folate-dependent antimetabolites.

What is the current clinical trials landscape for levoleucovorin?

No complete, source-verifiable clinical trials dataset for levoleucovorin (study identifiers, sponsors, phases, enrollment status, top-line readouts, and near-term timelines) is available in the provided information, so a complete trials update cannot be produced.

Which active clinical trial categories are most likely to involve levoleucovorin?

Levoleucovorin development and studies typically cluster into these intent areas:

• Combination regimen optimization with fluoropyrimidines and related agents (dose intensity, schedule changes).
• Biomarker or patient subgroup studies targeting toxicity mitigation or response stratification within fluoropyrimidine-based oncology.
• Comparative formulations (route of administration and stability) and biosimilar/bioequivalence-type evidence for follow-on products.

A trials update with phase-by-phase status and dates requires a complete registry extract and cannot be assembled from the provided material.

What is the market size for levoleucovorin and how is demand trending?

No verified market sizing, country-level sales, unit consumption, or cohort revenue attribution for levoleucovorin is available in the provided information, so a quantified market analysis cannot be produced.

What drivers are likely to affect levoleucovorin sales?

Market drivers for levoleucovorin are typically tied to:

• Fluoropyrimidine chemotherapy utilization (incidence of cancers where 5-FU or capecitabine regimens are standard).
• Oncology regimen inclusion in national guidelines and institutional protocols.
• Competitive supply from generic leucovorin and enantiomer-specific follow-ons.
• Pricing pressure once patents and exclusivity end.
• Formulation and procurement dynamics in hospital markets.

A projection requires sales baselines, competitive entry timing, and pricing assumptions, none of which are provided.

When does levoleucovorin lose exclusivity?

No patent or exclusivity record for levoleucovorin is included in the provided information, so exclusivity and expiration timing cannot be stated.

What generic entry risks exist for levoleucovorin?

A generic risk assessment needs:

• Orange Book listed patents and their expiration dates,
• any Paragraph IV filings and litigation/settlement records,
• and the relevant NDA/ANDA/RLD linkage.

None of these are available in the provided material, so a credible entry-risk map cannot be produced.

What is the Orange Book status of levoleucovorin?

No Orange Book listing information for levoleucovorin is provided. Without it, the Orange Book status cannot be determined.

How do levoleucovorin products compare with leucovorin (racemic) in market access and uptake?

A comparative commercial and formulary analysis depends on:

• which active ingredient variant is on formulary (racemic leucovorin vs enantiopure levoleucovorin),
• guideline language,
• payer and hospital contract structures,
• and evidence that differentiates efficacy or tolerability.

The provided information does not include these product-specific details.

Commercial projection: what revenue might levoleucovorin generate over the next 5 years?

A 5-year revenue projection requires an anchor:

• current sales by geography and channel,
• forecast drivers (incidence, guideline share, utilization),
• pricing trend and discount rate,
• expected competitive entries and patent timelines,
• and scenario definitions (base/upside/downside).

No such inputs are present, so a projection cannot be produced.

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Key Takeaways

• A clinical trials update for levoleucovorin requires registry-level evidence (study IDs, phases, sponsors, endpoints, and timelines), which is not provided.
• A market analysis and 5-year revenue projection require baseline sales and competitive entry assumptions, which are not provided.
• Exclusivity, Orange Book status, and generic entry risks depend on specific patent and regulatory record inputs that are not included.

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FAQs

1. What regulatory pathway does levoleucovorin use in the US (NDA vs ANDA) and how does that affect competition?
2. Which cancers and chemotherapy regimens most commonly include levoleucovorin in clinical practice?
3. What endpoints do levoleucovorin combination studies typically use in oncology (response rate, toxicity, survival)?
4. How do enantiopure levoleucovorin products compete against generic racemic leucovorin on price and formulary access?
5. What factors most influence hospital purchasing decisions for rescue agents like levoleucovorin (unit cost, supply stability, dosing convenience)?

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References

No sources were provided in the prompt, and no source-verifiable regulatory or trials data is included above.