MedPath

Lenograstim

Generic Name
Lenograstim
Drug Type
Biotech
CAS Number
135968-09-1
Unique Ingredient Identifier
6WS4C399GB

Overview

Lenograstim is a recombinant granulocyte colony-stimulating factor used as an immunostimulating agent.

Indication

The drug is used to reduce the risk of life-threatening infection in patients with neutropenia, particularly after cytotoxic chemotherapy. Lenograstim is indicated as a treatment to reduce the duration of neutropenia and the severity of infections in patients with non-myeloid malignancy who have undergone autologous or allogeneic bone marrow transplantation, or treatment with established cytotoxic chemotherapy and in addition to reduce the incidence of infection associated with established cytotoxic chemotherapy. Lenograstim is also indicated to mobilise peripheral blood progenitor cells (PBPCs) with Lenograstim alone, or after myelosuppressive chemotherapy, in order to accelerate haematopoietic recovery by infusion of such cells, after myelosuppressive or myeloablative therapy. Lenograstim is also indicated to accelerate the engraftment of these cells after their reinfusion. GRANOCYTE is also indicated for the treatment of severe chronic neutropenia including congenital agranulocytosis (Kostmann's syndrome).

Associated Conditions

  • Neutropenia

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2022/10/26
Phase 1
Recruiting
2018/04/13
Not Applicable
UNKNOWN
DERSHENG SUN
2014/12/18
Phase 3
Completed
PETHEMA Foundation
2014/07/09
Not Applicable
UNKNOWN
2013/07/24
Phase 2
Terminated
2010/08/12
Phase 2
Completed
University of Ulm
2010/04/21
Phase 4
Completed
2010/03/11
Phase 2
Completed
WiSP Wissenschaftlicher Service Pharma GmbH
2009/07/03
Phase 3
UNKNOWN
2008/04/01
Phase 2
Completed

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
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Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

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Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

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No HSA approvals found for this drug.

NMPA Drug Approvals

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No NMPA approvals found for this drug.

PPB Drug Approvals

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Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

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ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

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Company
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Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
GRANOCYTE 34 MILLONES DE UI POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE O PERFUSION
60211
POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE
Uso Hospitalario
Not Commercialized
GRANOCYTE 13 MILLONES DE UI POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE O PERFUSION
60672
POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE
Uso Hospitalario
Not Commercialized

Philippines FDA Drug Approvals

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No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

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No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

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No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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