Prevymis

(Letermovir)

ApprovedSmall molecule

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Prevymis is a small molecule that works as a DNA Terminase Inhibitor.[2] It is being used across 14 indications, with its most advanced program in Approved.[1]

Prevymis is one of 339 small molecule programs targeting HIV infection. It is currently in Approved.

Indications

Total Trials

Active Trials

338

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

HIV InfectionApproved

Viral DiseaseActive, not recruiting

HistiocytosisActive, not recruiting

HIV-1 InfectionActive, not recruiting

Cytomegalovirus InfectionActive, not recruiting

Kidney DiseaseActive, not recruiting

Kidney TransplantActive, not recruiting

Hematopoietic and Lymphoid Cell NeoplasmApproved

ImmunodeficiencyActive, not recruiting

Congenital Cytomegalovirus InfectionCompleted

HIV InfectionApproved

Approved

Viral DiseaseApproved

Active, not recruiting

HistiocytosisPreclinical

Active, not recruiting

HIV-1 InfectionPhase 2

Active, not recruiting

Cytomegalovirus InfectionApproved

Active, not recruiting

Kidney DiseasePhase 1

Active, not recruiting

Kidney TransplantPhase 3

Active, not recruiting

Hematopoietic and Lymphoid Cell NeoplasmApproved

Approved

ImmunodeficiencyPhase 2

Active, not recruiting

Congenital Cytomegalovirus InfectionPhase 1

Completed

Showing 10 of 14 indications

Competition

Competitive Landscape

476 competitors in Kidney Transplant

#DrugCompanyPhaseTrials

Prevymis

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Approved

3 2

Medrol

Pfizer

Preclinical

12 3

Zinbryta

Roche

Preclinical

6 4

Zemplar

AbbVie

Preclinical

2 5

Epogen

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Preclinical

1 6

Cysteine Hydrochloride

Novartis

Preclinical

1 7

Sensipar

Amgen

Preclinical

1 8

Precedex

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Preclinical

4 9

Jardiance

Boehringer Ingelheim

Preclinical

3 10

Nydrazid

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 2Recruiting

Transplant Recipient

NCT06066957

Phase 3Active, not recruiting

Kidney Transplant

NCT06001320

Phase 3Recruiting

Transplant Recipient

NCT06407232

Q4 2026

Post-ApprovalRecruiting

Cytomegalovirus Infection

NCT07266467

N/ARecruiting

Histiocytosis

NCT07488728

N/ARecruiting

Hematopoietic Cell Transplant Recipient

NCT06639854

Clinical

Trials by Indication[1]

Cytomegalovirus Infection10 trials

Letermovir for Primary Prophylaxis of Cytomegalovirus Infection After R+HID-HSCT

Unknown status·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 4·NCT05914675·21 enrolled

Efficacy and Safety of Leymovir Versus Valganciclovir in Prevention of Cytomegalovirus Infection and Cytomegalovirus Disease in Chinese Kidney Transplant Recipients

Recruiting·FFirst Affiliated Hospital Xi'an Jiaotong University·Phase 4·NCT07266467·290 enrolled

Letermovir Treatment for Refractory or Resistant Cytomegalovirus Infection

Completed·—·Phase 2·NCT03728426·10 enrolled

Show 7 more trials

Prenatal Treatment of Congenital Cytomegalovirus Infection with Letermovir Versus Valaciclovir

Recruiting·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT05446571·46 enrolled

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

Not yet recruiting·HHospital do Rim e Hipertensão·Phase 3·NCT06341686·100 enrolled

Prenatal Treatment of Congenital Cytomegalovirus Infection With Letermovir Randomized Against Valaciclovir - CYMEVALIII STEP1

Completed·AAssistance Publique - Hôpitaux de Paris·N/A·NCT04732260·7 enrolled

A Study of the Drug Letermovir as Prevention of Cytomegalovirus Infection After Stem Cell Transplant in Pediatric Patients

Recruiting·CChildren's Oncology Group·Phase 3·NCT05711667·105 enrolled

A Study of Letermovir (MK-8228) to Evaluate Efficacy and Safety for Prevention of Cytomegalovirus Infection in Chinese Hematopoietic Stem Cell Transplant Recipients (MK-8228-045)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT05763823·120 enrolled

Combination Letermovir and Standard of Care Antiviral for Enhanced Antiviral Response in Cytomegalovirus Infection in Lung Transplant Recipients

Recruiting·UUniversity Health Network, Toronto·Phase 4·NCT07235683·40 enrolled

Letermovir-based Dual Therapy for Treatment of Cytomegalovirus Infections

Recruiting·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT06334497·80 enrolled

Prophylaxis4 trials

CMV-TCIP Directed Letermovir Prophylaxis After Allo-SCT

Recruiting·UUniversity of California, Irvine·Phase 2·NCT06453460·50 enrolled

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

Recruiting·—··NCT06441669·60 enrolled

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

Active, not recruiting·RRuijin Hospital·Phase 3·NCT06449586·250 enrolled

Show 1 more trial

A Phase 1, Open-label, Single-arm Study to Evaluate the Pharmacokinetics and Safety of Letermovir in Pediatric Kidney Transplant (KT) Recipients Less Than 18 Years of Age and Weighing Less Than 40 Kilograms

Recruiting· Merck & Co. logo

Merck & Co.·Phase 1·NCT07199465·40 enrolled

Kidney Transplant3 trials

Letermovir Versus Valganciclovir to Prevent Human Cytomegalovirus Disease in Kidney Transplant Recipients (MK-8228-002)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT03443869·601 enrolled

De-novo Initiation of Letermovir vs Valganciclovir for Cytomegalovirus Prophylaxis in AA Kidney Transplant Recipients

Active, not recruiting·VVirginia Commonwealth University·Phase 3·NCT06001320·60 enrolled

MK-8228 (Letermovir) in the Prevention of Human Cytomegalovirus (CMV) Infection and Disease in Adult Japanese Kidney Transplant Recipients (MK-8228-042)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT04129398·22 enrolled

Transplant Recipient3 trials

Open Label Trial of Oral Letermovir for CMV Prophylaxis in Thoracic Transplant Recipients

Recruiting·UUniversity of Pennsylvania·Phase 2·NCT06066957·80 enrolled

Letermovir Use in Heart Transplant Recipients

Completed·TTufts Medical Center·Phase 4·NCT04904614·32 enrolled

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

Recruiting·UUniversity of Wisconsin, Madison·Phase 3·NCT06407232·90 enrolled

CMV Infection2 trials

Letermovir Prophylaxis for CMV Infection in Haplo-HSCT Recipients: Single-center Data in China

Completed·TThe First Affiliated Hospital of Soochow University··NCT05789615·200 enrolled

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

Recruiting·CCao Weijie··NCT06306989·150 enrolled

21 more indications

Hematopoietic Stem Cell Transplant (HSCT)1 trial

Extension of Letermovir (LET) From Day 100 to Day 200 Post-transplant for the Prevention of Cytomegalovirus (CMV) Infection in Hematopoietic Stem Cell Transplant (HSCT) Participants (MK-8228-040)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT03930615·220 enrolled

ART1 trial

Letermovir in ART-treated HIV-infected Persons

Completed·JJean-Pierre Routy·N/A·NCT05362916·33 enrolled

Histiocytosis1 trial

Letermovir Prophylaxis in Children With EBV-Positive T/NK-Cell Lymphoproliferative Disease and Refractory/Relapsed EBV-Associated Hemophagocytic Lymphohistiocytosis

Recruiting·—·N/A·NCT07488728·80 enrolled

HIV-1 infection1 trial

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

Not yet recruiting·UUniversity College, London·Phase 2·NCT06626555·36 enrolled

Heart Transplant1 trial

Valganciclovir vs. Letermovir for CMV Prophylaxis in Heart Transplant

Recruiting·—·Phase 2/3·NCT07079735·150 enrolled

Not yet recruiting·JJason A Roberts·Phase 1·NCT07101055·20 enrolled

Allogeneic Haematopoietic Stem Cell Transplantation1 trial

Letermovir Treatment in Pediatric Participants Following Allogeneic Haematopoietic Stem Cell Transplantation (HSCT) (MK-8228-030)

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT03940586·65 enrolled

Cytomegalovirus (CMV) Infection1 trial

Efficacy of Letermovir in Preventing Cytomegalovirus (CMV) Infection in Lung Transplant Recipients vs. Valganciclovir.

Not yet recruiting·MMaimónides Biomedical Research Institute of Córdoba·Phase 2·NCT06057194·90 enrolled

Hematopoietic Stem Cell Transplantation1 trial

Triplex Vaccine in Preventing CMV Infection in Patients Undergoing Hematopoietic Stem Cell Transplantation

Active, not recruiting·—·Phase 2·NCT04060277·7 enrolled

Allogeneic Hematopoietic Stem Cell Transplant Recipient1 trial

Letermovir (MK-8228) Versus Placebo in the Prevention of Clinically-Significant Cytomegalovirus (CMV) Infection in Adult, CMV-Seropositive Allogeneic Hematopoietic Stem Cell Transplant Recipients (MK-8228-001)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT02137772·570 enrolled

Elranatamab1 trial

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

Recruiting·SSeoul National University Hospital·Phase 2·NCT06920251·40 enrolled

Graft Versus Host Disease1 trial

Letermovir Prophylaxis for Cytomegalovirus (CMV) in Patients With Graft-versus-host Disease

Unknown status·RRabin Medical Center·Phase 2·NCT05969743·42 enrolled

Hematopoietic Cell Transplant Recipient1 trial

The Use of Cytomegalovirus Cell Mediated Immunity to Optimize the Duration of Letermovir Prophylaxis in Hematopoietic Cell Transplant Recipients

Recruiting·MM.D. Anderson Cancer Center·N/A·NCT06639854·105 enrolled

T Cell1 trial

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

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT06575374·36 enrolled

Immune1 trial

Immune Reconstitution to CMV After HSCT: Impact of Clinical Factors and Therapy Strategies

Unknown status·PPeking University People's Hospital··NCT05656599·120 enrolled

Lung Transplantation1 trial

Letermovir for CMV Prevention After Lung Transplantation

Completed·FFernanda P Silveira, MD, MS·Phase 2·NCT05041426·16 enrolled

Solid Organ Transplant Recipients1 trial

Letermovir for Secondary Prophylaxis in Solid Organ Transplant Recipients

Recruiting·TTufts Medical Center·Phase 4·NCT05626530·25 enrolled

Congenital Cytomegalovirus Infection1 trial

A Phase I Pharmacokinetic and Safety Assessment of Oral Letermovir in Infants With Symptomatic Congenital Cytomegalovirus Disease

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT06118515·3 enrolled

Chronic Myeloid Leukemia, BCR-ABL1 Positive1 trial

A Phase 1b Trial of CMV-MVA Triplex Vaccine in Haploidentical Stem Cell Donors and Recipients to Enhance CMV-Specific Immunity and Prevent CMV Viremia in Recipients of Hematopoietic Stem Cell Transplant

Recruiting·CCity of Hope Medical Center·Phase 1·NCT07020533·46 enrolled

Regulatory

FDA Approval Timeline[4]

Nov 8, 2017

PREVYMIS

NDA NDA209940

Nov 8, 2017

PREVYMIS

NDA NDA209939

Aug 30, 2024

PREVYMIS

NDA NDA219104

Sources

References

[1]
ClinicalTrials.gov — 43 trial records for Letermovir. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Letermovir compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Letermovir. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA219104). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Prevymis. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: DNA Terminase Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Patent Landscape[5]

Patent Cliff

Jan 18, 2029

Earliest patent expiration — generic entry possible after this date

Patent #Expires

RE46791Jan 18, 2029

10603384Feb 28, 2033

Prevymis

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Trials by Indication[1]

Cytomegalovirus Infection10 trials

Prophylaxis4 trials

Kidney Transplant3 trials

Transplant Recipient3 trials

CMV Infection2 trials

Hematopoietic Stem Cell Transplant (HSCT)1 trial

ART1 trial

Histiocytosis1 trial

HIV-1 infection1 trial

Heart Transplant1 trial

Hematological Malignancies1 trial

Immunodeficiency1 trial

Kidney Disease1 trial

Allogeneic Haematopoietic Stem Cell Transplantation1 trial

Cytomegalovirus (CMV) Infection1 trial

Hematopoietic Stem Cell Transplantation1 trial

Allogeneic Hematopoietic Stem Cell Transplant Recipient1 trial

Elranatamab1 trial

Graft Versus Host Disease1 trial

Hematopoietic Cell Transplant Recipient1 trial

T Cell1 trial

Immune1 trial

Lung Transplantation1 trial

Solid Organ Transplant Recipients1 trial

Congenital Cytomegalovirus Infection1 trial

Chronic Myeloid Leukemia, BCR-ABL1 Positive1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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