MedPath

Letermovir

Generic Name
Letermovir
Brand Names
Prevymis
Drug Type
Small Molecule
Chemical Formula
C29H28F4N4O4
CAS Number
917389-32-3
Unique Ingredient Identifier
1H09Y5WO1F
Background

Letermovir recieved approval from the FDA on November 8th, 2017 for use in prophylaxis of cytomegalovirus (CMV) infection in allogeneic hematopoietic stem cell transplant patients. It is the first of a new class of CMV anti-infectives called DNA terminase complex inhibitors. Letermovir has recieved both priority and orphan drug status from the FDA. It is currently marketed under the brand name Prevymis.

Indication

Letermovir is indicated for prophylaxis against cytomegalovirus (CMV) infection and disease in adult recipients of an allogeneic hematopoietic stem cell transplant (HSCT) who are CMV-seropositive. It is also indicated for prophylaxis against CMV disease in adult kidney transplant recipients who are at risk (i.e. donor CMV-seropositive/recipient CMV-seronegative).

Associated Conditions
Cytomegalovirus (CMV) Infections

Phase II Trials of Letermovir Prophylaxis in Patients With RRMM Undergoing Elranatamab Therapy

Phase 2
Not yet recruiting
Conditions
Relapsed Refractory Multiple Myeloma (RRMM)
Interventions
First Posted Date
2025-04-09
Last Posted Date
2025-05-01
Lead Sponsor
Seoul National University Hospital
Target Recruit Count
40
Registration Number
NCT06920251
Locations
🇰🇷

Seoul National University Hospital, Seoul, Korea, Republic of

Clinical Trial to Evaluate the Effects of Letermovir Prophylaxis on T-cell Immune Activation in Participants With Treated HIV-1 Infection

Phase 2
Not yet recruiting
Conditions
HIV
Interventions
First Posted Date
2024-10-04
Last Posted Date
2024-10-04
Lead Sponsor
University College, London
Target Recruit Count
36
Registration Number
NCT06626555

Single Arm Pilot Trial of Letermovir for CMV Prophy in CAR T Cell

Phase 2
Recruiting
Conditions
Cell Therapy
Interventions
First Posted Date
2024-08-28
Last Posted Date
2025-02-20
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
36
Registration Number
NCT06575374
Locations
🇺🇸

MD Anderson Cancer Center, Houston, Texas, United States

Prospect Eval of Efficacy of CMV-TCIP Direct Letermovir Prophylax After Allogen Hemato Cell Transpla

Phase 2
Recruiting
Conditions
CMV
Allogeneic Stem Cell Transplantation
Interventions
Device: CMV T Cell Immunity Panel (CMV-TCIP)
Diagnostic Test: CMV DNA PCR
First Posted Date
2024-06-11
Last Posted Date
2024-07-15
Lead Sponsor
University of California, Irvine
Target Recruit Count
50
Registration Number
NCT06453460
Locations
🇺🇸

Chao Family Comprehensive Cancer Center, University of California Irvine, Orange, California, United States

CMV-specific T Cell Immunity Test Indicated Prophylaxis of Letermovir After All-HSCT

Not Applicable
Recruiting
Conditions
Hematologic Malignancy
Interventions
First Posted Date
2024-06-10
Last Posted Date
2025-01-09
Lead Sponsor
Ruijin Hospital
Target Recruit Count
250
Registration Number
NCT06449586
Locations
🇨🇳

Tongji Hospital of Huazhong University of Science and Technology, Wuhan, Wuhan, Hubei, China

🇨🇳

Ruijin Hospital of Shanghai Jiaotong University, Shanghai, Shanghai, China

🇨🇳

The First Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China

and more 2 locations

Effect of Letermovir Prophylaxis on CMV-specific Immune Reconstitution Post UCBT

Recruiting
Conditions
Cytomegalovirus Infection Reactivation
Interventions
First Posted Date
2024-06-04
Last Posted Date
2024-06-04
Lead Sponsor
Anhui Provincial Hospital
Target Recruit Count
60
Registration Number
NCT06441669
Locations
🇨🇳

Anhui Provincial Hospital, Hefei, Anhui, China

Letermovir (Prevymis) for CMV in Kidney and Pancreas Transplant Recipients

Phase 3
Recruiting
Conditions
Pancreas Transplant
Cytomegalovirus Infections
Kidney Transplant Infection
Interventions
First Posted Date
2024-05-09
Last Posted Date
2024-08-20
Lead Sponsor
University of Wisconsin, Madison
Target Recruit Count
90
Registration Number
NCT06407232
Locations
🇺🇸

UW Hospital and Clinics, Madison, Wisconsin, United States

Evaluation of the Prophylactic Use of Letermovir in Kidney Transplant Recipients at Risk of Cytomegalovirus Infection

Phase 3
Not yet recruiting
Conditions
CMV Infection
Interventions
First Posted Date
2024-04-02
Last Posted Date
2024-04-02
Lead Sponsor
Hospital do Rim e Hipertensão
Target Recruit Count
100
Registration Number
NCT06341686

Letermovir-based Dual Therapy for Treatment of Cytomegalovirus Infections

Phase 3
Recruiting
Conditions
Cytomegalovirus Infection
Interventions
First Posted Date
2024-03-28
Last Posted Date
2025-03-25
Lead Sponsor
Assistance Publique - Hôpitaux de Paris
Target Recruit Count
80
Registration Number
NCT06334497
Locations
🇫🇷

Hôpital Necker Enfants Malades, Paris, France

Observational Clinical Study of Letermovir for Preventing CMV Infection After Allo-HSCT

Recruiting
Conditions
Letemovir for the Prevention of CMV Infection After Allo-HSCT
Interventions
First Posted Date
2024-03-12
Last Posted Date
2024-03-12
Lead Sponsor
Cao Weijie
Target Recruit Count
150
Registration Number
NCT06306989
Locations
🇨🇳

Cao, Weijie, Zhengzhou, Henan, China

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