Daklinza

(Daclatasvir)

ApprovedSmall molecule

Daclatasvir is used to treat hepatitis C virus (HCV) infection, a liver disease caused by a virus. It works by stopping the virus from reproducing in the body, often used in combination with other antiviral medications.[2] Daklinza is currently approved and in use across 4 indications[4].[1]

Daklinza is one of 122 small molecule programs targeting Viral Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

121

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Viral DiseaseActive, not recruiting

Hepatitis C Virus InfectionActive, not recruiting

Chronic Kidney DiseaseApproved

Hepatic FailureApproved

Viral DiseaseApproved

Active, not recruiting

Hepatitis C Virus InfectionApproved

Active, not recruiting

Chronic Kidney DiseaseApproved

Approved

Hepatic FailureApproved

Approved

Competition

Competitive Landscape

172 competitors in Chronic Kidney Disease

#DrugCompanyPhaseTrials

Daklinza

Bristol-Myers Squibb

Approved

68 2

Uloric

Takeda

Preclinical

2 3

Sovaldi

Gilead

Preclinical

1 4

Glucotrol

Pfizer

Preclinical

1 5

Vemlidy

Gilead

Preclinical

1 6

Lorelco

Sanofi

Preclinical

1 7

Activase

Flomax

Januvia

ZZydus Therapeutics Inc.

Preclinical

1 10

Baraclude

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Preclinical

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

Clinical

Trials by Indication[1]

Chronic Hepatitis18 trials

A Phase 3 Evaluation of Daclatasvir and Asunaprevir in Treatment-naive Subjects With Chronic Hepatitis C Genotype 1b Infection

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT02496078·207 enrolled

Efficacy and Safety of All-Oral Combination of Narlaprevir/Ritonavir and Daclatasvir in Treatment-Naїve Patients With Chronic Hepatitis C Genotype 1b

Completed·RR-Pharm·Phase 2·NCT03485846·105 enrolled

A Study of Pharmacokinetics, Efficacy, Safety, Tolerability, of the Combination of Simeprevir (TMC435), Daclatasvir (BMS-790052), and Ribavirin (RBV) in Patients With Recurrent Chronic Hepatitis C Genotype 1b Infection After Orthotopic Liver Transplantation

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT01938625·35 enrolled

Show 15 more trials

UNITY 2: A Study of an Investigational Treatment Regimen of DCV+ASV+BMS-791325 in a Fixed Dose Combination (the DCV 3DAA (Direct Acting Antiviral) Regimen) With or Without RBV for 12 Weeks for the Treatment of Chronic Hepatitis C Virus(HCV)Genotype 1 Infection in Subjects With Compensated Cirrhosis

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT01973049·202 enrolled

A Study to Assess the Efficacy and Safety of the Combination of Simeprevir and Daclatasvir in Chronic Hepatitis C Genotype 1b-Infected Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT02268864·106 enrolled

Study in Genotype 2 or 3 Patients With Chronic Hepatitis Virus Infection

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT01257204·196 enrolled

Evaluation of Daclatasvir (DCV) in Combination With Sofosbuvir (SOF) in Children With Chronic Hepatitis C (CHC) Infection

Terminated· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT03487848·5 enrolled

A Phase 2 Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-135 and Daclatasvir in Subjects With Genotype 1 Chronic Hepatitis C Chronic Hepatitis C

Completed· Vertex Pharmaceuticals logo

Vertex Pharmaceuticals·Phase 2·NCT01842451·23 enrolled

A Multicenter Treatment Protocol of Daclatasvir (BMS-790052) in Combination With Sofosbuvir for the Treatment of Post-Liver Transplant Subjects With Chronic Hepatitis C

No longer available· Bristol-Myers Squibb logo

Bristol-Myers Squibb··NCT02161939

Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of Simeprevir, Daclatasvir and Sofosbuvir in Treatment-naive Participants With Chronic Hepatitis C Virus Genotype 1 Infection

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT02349048·68 enrolled

An Efficacy, Safety, Tolerability and Pharmacokinetics Study of 12 Weeks Treatment With Simeprevir and Daclatasvir in Participants With Chronic Hepatitis C Virus Genotype 1b or 4 Infection and Either Severe Renal Impairment or End-stage Renal Disease on Hemodialysis.

Withdrawn· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT02397395

An Efficacy, Safety and Pharmacokinetics Study of Simeprevir, Daclatasvir and Sofosbuvir in Participants With Chronic Hepatitis C Virus Genotype 1 or 4 Infection and Decompensated Liver Disease

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT02262728·40 enrolled

Phase 2b Study of BMS-986094 and Daclatasvir, With or Without Ribavirin for the Treatment of Patients With Chronic Hepatitis C

Withdrawn· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT01629732

A Phase 2b Evaluation of Daclatasvir/Sofosbuvir in Non-Cirrhotic Treatment Naive Subjects With Genotype 1, 2, 3 and 4 Chronic Hepatitis C Virus Coinfected With Human Immunodeficiency Virus (HIV-1)

Withdrawn· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT02556086

A Randomized, Open-Label Study of Daclatasvir and Sofosbuvir With or Without Ribavirin for 8 Weeks in Treatment-Naïve, Non-cirrhotic Subjects Infected With Chronic Hepatitis C Virus (HCV) Genotype 3

Withdrawn· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT02551861

EU: A Multicenter Compassionate Use Program of Daclatasvir (BMS-790052) in Combination With Sofosbuvir With or Without Ribavirin for the Treatment of Subjects With Chronic Hepatitis C

No longer available· Bristol-Myers Squibb logo

Bristol-Myers Squibb··NCT02097966

Study of Daclatasvir (BMS-790052) and Simeprevir (TMC435) in Patients With Genotype 1 Chronic Hepatitis C Virus

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT01628692·230 enrolled

UNITY 3: A Japanese Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 in Subjects With Genotype 1 Chronic Hepatitis C

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT02123654·297 enrolled

Hepatitis C13 trials

A Single Ascending Dose Study of Daclatasvir (BMS-790052) in Hepatitis C Virus Infected Subjects

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1/2·NCT00546715·95 enrolled

Role of Pegylated Interferon in Combination With DAAs to Cure Hepatitis C As Soon As Possible - Hepatitis C [ASAP-C]

Completed·JJohns Hopkins Bloomberg School of Public Health·Phase 2/3·NCT03480932·150 enrolled

Study to Determine the Safety and Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) in Patients Who Have Previously Not Received the Standard of Care

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT01359644·350 enrolled

Show 10 more trials

A Multiple Ascending Dose Study of Daclatasvir (BMS-790052) in Hepatitis C Virus Genotype 1 Infected Subjects

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT00663208·167 enrolled

BMS-790052 (Daclatasvir) Plus Peg-Interferon Alfa-2a and Ribavirin in Treatment-Naive Black/African-Americans, Latinos and White/Caucasians With Hepatitis C

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT01389323·448 enrolled

Safety and Efficacy Study of Pegylated Interferon Lambda With and Without Daclatasvir, Compared to Pegylated Interferon Alfa, Plus Ribavirin in Subjects With Hepatitis C Genotype 2 and 3

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT01616524·880 enrolled

Study of pegInterferon Alfa-2a, Ribavirin, and Daclatasvir (BMS-790052) With or Without BMS-650032 for Participants in Some Hepatitis C Virus Trials

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT01428063·276 enrolled

Determining the Sustained Virologic Response of Declatasvir in Egyptian Patients With Hepatitis C Virus Genotype 4

Unknown status·ZZagazig University··NCT02772744·250 enrolled

Safety and Efficacy Study of Daclatasvir (BMS-790052) Plus Pegylated Interferon-Alfa 2a and Ribavirin in Patients Coinfected With Untreated Hepatitis C Virus and HIV Virus

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT01471574·549 enrolled

Study of AT-527 in Combination With Daclatasvir in Subjects With Hepatitis C Virus (HCV) Infection

Completed·AAtea Pharmaceuticals, Inc.·Phase 2·NCT04019717·10 enrolled

A Phase 3 Study to Evaluate Combination Therapy With Daclatasvir and Sofosbuvir in the Treatment of HIV and Hepatitis C Virus Coinfection.

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT02032888·238 enrolled

Safety and Efficacy of Sofosbuvir-Based Regimens in the Treatment of Egyptian Patients With Hepatitis C Infection

Completed·TTanta University·Phase 4·NCT02992457·10,000 enrolled

Sofosbuvir, Daclatasvir, Ribavirin for Hepatitis C Virus (HCV) Cirrhotics

Completed·TTehran University of Medical Sciences·Phase 3·NCT02596880·100 enrolled

Efficacy and Safety5 trials

Efficacy and Safety Evaluation of a Regimen Consisting of Peginterferon Lambda-1a + Ribavirin + Daclatasvir (Lambda + RBV + DCV) in HCV Genotype 1b Treatment naïve Patients or Prior Relapsers to Peginterferon Alfa + Ribavirin (Alfa + RBV) Therapy

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT01718158·444 enrolled

Efficacy and Safety of Therapy Against HCV Based on Direct-acting Antivirals in Real-life Conditions

Completed·VValme University Hospital··NCT02333292·1,128 enrolled

A Study Comparing Efficacy and Safety of ABT-493/ABT-530 to Sofosbuvir Dosed With Daclatasvir in Adults With HCV Genotype 3 Infection

Completed· AbbVie logo

AbbVie·Phase 3·NCT02640157·506 enrolled

Show 2 more trials

Efficacy and Safety Study of Pegylated Interferon Lambda-1a With Ribavirin and Daclatasvir, to Treat naïve Subjects With Chronic HCV Genotypes 1, 2, 3, and 4 Who Are Co-infected With HIV

Terminated· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT01866930·453 enrolled

Efficacy and Safety Evaluation of a Treatment Consisting of Peg Interferon Alfa + Ribavirin + Daclatasvir in HCV Genotype 1 and 4 Treatment naïve Patients

Withdrawn· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT01797848

Treatment4 trials

Sofosbuvir in Treatment of COVID 19

Unknown status·TTanta University·Phase 2/3·NCT04460443·60 enrolled

SOF Plus DCV in Treating Chinese Treatment-experienced HCV Patients

Completed·HHumanity and Health Research Centre·Phase 2/3·NCT02473211·106 enrolled

Sofosbuvir Containing Regimens in Treatment of COVID 19 Patients

Unknown status·TTanta University·Phase 2/3·NCT04497649·100 enrolled

Show 1 more trial

Study of Daclatasvir (BMS-790052) Add-on to Standard of Care in Treatment- naïve Patients

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT01125189·558 enrolled

Phase II4 trials

Phase III Daclatasvir and Sofosbuvir for Genotype 3 Chronic HCV

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT02032901·173 enrolled

Phase III Hallmark QUAD: ASV+DCV+Peg+Rib (Nulls/Partials)

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT01573351·398 enrolled

Phase III Hallmark DUAL: ASV+DCV (Nulls/Partials, Intolerants/Ineligibles. Naives)

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT01581203·748 enrolled

Show 1 more trial

Phase III China GT 1b Interferon (IFN) Intolerant Prev Exclude Dual

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT01995266·218 enrolled

17 more indications

Safety and Efficacy4 trials

Chronically-infected HCV Genotype 2 and 3 Treatment-naive Subjects: Part A: Safety and Efficacy of INX-08189 With Peg IFN Alfa-2a and Ribavirin. Part B: INX-08189 in Interferon Free Treatment With Daclatasvir and/or Ribavirin

Terminated· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT01425970·210 enrolled

Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care (Pegylated-interferon Alpha and Ribavirin)

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT00874770·74 enrolled

Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care in Japanese Patients (Pegylated-interferon Alpha-2a and Ribavirin)

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT01017575·55 enrolled

Show 1 more trial

Study to Evaluate the Safety and Efficacy of Daclatasvir/Sofosbuvir/Ribavirin for 16 Versus 24 Weeks for HCV Genotype 3 Cirrhotics

Completed·TTarek I. Hassanein, M.D., FACP, FAG, AGAF·Phase 4·NCT02304159·39 enrolled

ACL2 trials

Daclatasvir, Asunaprevir Plus Ribavirin for HCV Genotype 1b Without NS5A RAV

Completed·KKaohsiung Medical University Chung-Ho Memorial Hospital·Phase 3·NCT03004625·70 enrolled

A Bioequivalence Study of Daclatasvir Tablets and Bioavailability Studies of Daclatasvir and Asunaprevir

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT02323594·88 enrolled

Age2 trials

Comparative Study of Two Regiemns in Management of Sofosbuvir/Daclatasvir Failure

Completed·—·N/A·NCT03549832·40 enrolled

Safety Study of Pegylated Interferon Lambda Plus Single or 2 Direct Antiviral Agents With Ribavirin

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT01795911·165 enrolled

Interaction2 trials

A Drug-drug Interaction Study Between Daclatasvir and Metformin

Completed·RRadboud University Medical Center·Phase 1·NCT02565862·20 enrolled

A Drug-drug Interaction Study Between Daclatasvir and Atazanavir/Ritonavir or Atazanavir/Cobicistat

Completed·RRadboud University Medical Center·Phase 1·NCT02565888·16 enrolled

Chronic2 trials

Impact of Interferon Free Regimens in Patients With Chronic HCV and Successfully Treated HCC

Unknown status·NNational Hepatology & Tropical Medicine Research Institute·Phase 3·NCT02771405·150 enrolled

Effect of ASV and DCV Therapy on the Quality of Immune Status in Chronic HCV Patients

Completed·FFoundation for Liver Research·Phase 3·NCT02282709·12 enrolled

Combination Therapy1 trial

A Phase 3, Comparative Study of Asunaprevir and Daclatasvir Combination Therapy Versus Telaprevir Therapy in Japanese HCV Subjects

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT01718145·258 enrolled

Hepatic Impairment1 trial

Study to Evaluate the Safety and PK of Elpida® in Healthy Subjects and Patients With Hepatic Impairment and to Assess the Impact of Food Intake and Drug-Drug Interactions With Other Antiviral Drugs

Completed·VViriom·Phase 1·NCT03706898·36 enrolled

Renal Impairment1 trial

Pharmacokinetic and Safety Study of Daclatasvir in Patients With Renal Impairment

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT01830205·58 enrolled

Hemophilia1 trial

Safety and Efficacy Study in Subjects With Chronic HCV and Underlying Hemophilia

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT01741545·71 enrolled

Liver Transplant1 trial

Phase III Daclatasvir, Sofosbuvir, and Ribavirin in Cirrhotic Participants and Participants Post-liver Transplant

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT02032875·116 enrolled

Metformin1 trial

Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetis and Pharmacodynamics of Metformin

Completed·MMohamed Raslan·Phase 1·NCT03686722·20 enrolled

Cirrhosis1 trial

Safety and Efficacy Study of the Combination Daclatasvir (60 mg), Sofosbuvir (400 mg) and Ribavirin (Weight-based Dosing) for 12 or 16 Weeks in Subjects With Genotype 3 Chronic HCV Infection With or Without Prior Treatment Experience and Advanced Fibrosis or Compensated Cirrhosis

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT02319031·53 enrolled

Tics1 trial

Study Assessing the Effects of Darunavir/Ritonavir or Lopinavir/Ritonavir on the Pharmacokinetics of Daclatasvir in Healthy Participants

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT02159352·49 enrolled

COVID-191 trial

Antiviral Agents Against COVID-19 Infection

Completed·HHospital do Coracao·Phase 2/3·NCT04468087·256 enrolled

Kidney Failure1 trial

Safety of Sofosbuvir in People With Advanced Kidney Failure

Completed·SSanjay Gandhi Postgraduate Institute of Medical Sciences·Phase 3·NCT03883698·30 enrolled

Chronic Hepatitis C Virus Infection1 trial

Study Comparing Daclatasvir (BMS-790052) With Telaprevir Combined With Peginterferon Alfa-2a and Ribavirin in Patients With Chronic Hepatitis C Virus Infection

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT01492426·605 enrolled

TED1 trial

Therapy With Asunaprevir, Daclatasvir, Ribavirin and Pegylated Interferon Alpha-2a in HCV Genotype 4-infected Patients Who Have Failed to a Previous Therapy With Peg-Interferon/Ribavirin (ANRS HC32 QUATTRO)

Completed·AANRS, Emerging Infectious Diseases·Phase 2·NCT02107365·60 enrolled

Regulatory

FDA Approval Timeline[5]

Jul 24, 2015

DAKLINZA

NDA NDA206843

Sources

References

[1]
ClinicalTrials.gov — 68 trial records for Daclatasvir. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Daklinza drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Daclatasvir compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Daclatasvir. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA206843). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Daklinza. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Bristol-Myers Squibb company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Nonstructural Protein 5a Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Bristol-Myers Squibb

Patent Landscape[6]

Patent Cliff

Aug 8, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8900566Aug 8, 2027

9421192Aug 8, 2027

8642025Aug 11, 2027

8329159Jul 24, 2029

8629171Jun 13, 2031

Daklinza

Status by Indication[4][1]

Competitive Landscape

Trials by Indication[1]

Chronic Hepatitis18 trials

Hepatitis C13 trials

Efficacy and Safety5 trials

Treatment4 trials

Phase II4 trials

Safety and Efficacy4 trials

ACL2 trials

Age2 trials

Interaction2 trials

Chronic2 trials

Combination Therapy1 trial

Hepatic Impairment1 trial

Renal Impairment1 trial

Hemophilia1 trial

Liver Transplant1 trial

Metformin1 trial

Cirrhosis1 trial

Tics1 trial

COVID-191 trial

Kidney Failure1 trial

Chronic Hepatitis C Virus Infection1 trial

TED1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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