LEUCOVORIN CALCIUM PRESERVATIVE FREE

Post-LOE

leucovorin calcium

Sagent Pharmaceuticals

ANDAINJECTIONINJECTABLE

Approved

Oct 2017

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

4/8 — Partial

LEUCOVORIN CALCIUM PRESERVATIVE FREE (leucovorin calcium) by Sagent Pharmaceuticals is clinical pharmacology leucovorin is a mixture of the diastereoisomers of the 5-formyl derivative of tetrahydrofolic acid (thf). Approved for the treatment of megaloblastic anemias due to folic acid deficiency, colorectal cancer. First approved in 2017.

Drug data last refreshed 1w ago

Mechanism of Action

CLINICAL PHARMACOLOGY Leucovorin is a mixture of the diastereoisomers of the 5-formyl derivative of tetrahydrofolic acid (THF). The biologically active compound of the mixture is the (-)- l -isomer, known as Citrovorum factor, or (-)-folinic acid. Leucovorin does not require reduction by the enzyme…

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Data Sources

Drug label: DailyMed / FDA
Clinical trials: ClinicalTrials.gov
Patent data: FDA Orange Book
Spending data: CMS Medicare

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.

Clinical Trials (7)

NCT04060017Phase 2Recruiting

Early Treatment of Language Impairment in Young Children With Autism Spectrum Disorder With Leucovorin Calcium

Started Sep 2020

80 enrolled

Autism Spectrum DisorderLanguage Disorders

NCT03337087Phase 1/2Active Not Recruiting

Liposomal Irinotecan, Fluorouracil, Leucovorin Calcium, and Rucaparib in Treating Patients With Metastatic Pancreatic, Colorectal, Gastroesophageal, or Biliary Cancer

Started Nov 2018

18 enrolled

Metastatic Biliary Tract CarcinomaMetastatic Colorectal CarcinomaMetastatic Gastroesophageal Junction Adenocarcinoma+6 more

NCT01238965Phase 1Terminated

Panobinostat and Fluorouracil Followed By Leucovorin Calcium in Treating Patients With Stage IV Colorectal Cancer Who Did Not Respond to Previous Fluorouracil-Based Chemotherapy

Started Oct 2010

7 enrolled

Recurrent Colon CancerRecurrent Rectal CancerStage IV Colon Cancer+1 more

NCT01150045Phase 3Unknown

Oxaliplatin, Leucovorin Calcium, and Fluorouracil With or Without Celecoxib in Treating Patients With Stage III Colon Cancer Previously Treated With Surgery

Started Jun 2010

2,527 enrolled

Colorectal Cancer

NCT00942266Phase 2Completed

Vorinostat, Fluorouracil, and Leucovorin Calcium in Treating Patients With Metastatic Colorectal Cancer That Has Not Responded to Previous Treatment

Started Jul 2009

58 enrolled

Adenocarcinoma of the ColonAdenocarcinoma of the RectumRecurrent Colon Cancer+3 more

LEUCOVORIN CALCIUM PRESERVATIVE FREE

Mechanism of Action

Indications (2)

Clinical Trials (7)