Pifeltro

(Doravirine)

ApprovedSmall molecule

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

Doravirine is used to treat HIV infection in adults. It works by blocking a protein that HIV needs to reproduce, helping to reduce the amount of virus in the body.[2] Pifeltro is currently approved and in use across 10 indications[4].[1]

Pifeltro is one of 329 small molecule programs targeting HIV. It is currently in Approved.

Indications

Total Trials

Active Trials

328

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

HIVActive, not recruiting

Viral DiseaseActive, not recruiting

HIV-1 InfectionActive, not recruiting

HIV InfectionActive, not recruiting

Kidney DiseaseApproved

TuberculosisActive, not recruiting

Human Immunodeficiency Virus (HIV)Recruiting

EfficacyRecruiting

Phase IIRecruiting

PregnancyRecruiting

HIVApproved

Active, not recruiting

Viral DiseaseApproved

Active, not recruiting

HIV-1 InfectionApproved

Active, not recruiting

HIV InfectionApproved

Active, not recruiting

Kidney DiseaseApproved

Approved

TuberculosisPreclinical

Active, not recruiting

Human Immunodeficiency Virus (HIV)Phase 2

Recruiting

EfficacyPhase 3

Recruiting

Phase IIPhase 2

Recruiting

PregnancyApproved

Recruiting

Competition

Competitive Landscape

145 competitors in Efficacy

#DrugCompanyPhaseTrials

Pifeltro

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

Approved

1 2

Biaxin

AbbVie

Phase 3

4 3

Vabysmo

Roche

Phase 3

2 4

Rogaine

Pfizer

Phase 3

1 5

Paraplatin

AAvyxa

Phase 3

4 6

Alimta

SShawn Eagle

Phase 3

3 7

Cytoxan

BBaxter Healthcare Corporation

Phase 3

3 8

Lesinurad

EEsperion Therapeutics, Inc.

Phase 3

2 9

Bystolic

VVitae Pharmaceuticals Inc., an Allergan affiliate

Phase 3

2 10

Insulin 320

Novo Nordisk

Phase 3

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

Timeline

Expected Milestones

Q4 2027

Phase 3Recruiting

Efficacy

NCT04892654

Q3 2028

Post-ApprovalRecruiting

Pregnancy

NCT05630638

Q2 2034

Phase 2Recruiting

Human Immunodeficiency Virus (HIV)

NCT04375800

Clinical

Trials by Indication[1]

Immunodeficiency4 trials

Islatravir (MK-8591) With Doravirine and Lamivudine in Participants Infected With Human Immunodeficiency Virus Type 1 (MK-8591-011)

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT03272347·123 enrolled

A Dose-Ranging Study to Compare Doravirine (MK-1439) Plus TRUVADA® Versus Efavirenz Plus TRUVADA® in Human Immunodeficiency Virus (HIV)-1 Infected Participants (MK-1439-007)

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT01632345·342 enrolled

A Study of Doravirine (MK-1439) in Human Immunodeficiency Virus Type 1 (HIV-1)-Infected Participants (MK-1439-005)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT01466985·18 enrolled

Show 1 more trial

Safety and Efficacy of Doravirine (MK-1439) in Participants With Human Immunodeficiency Virus 1 (HIV-1) (MK-1439-018)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT02275780·769 enrolled

Unknown status·UUniversity of Roma La Sapienza··NCT05202613·90 enrolled

Methadone1 trial

Effects of Doravirine (MK-1439) on Methadone Pharmacokinetics in Methadone-Maintained Participants (MK-1439-045)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT02715700·14 enrolled

16 more indications

Hepatic Insufficiency1 trial

A Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of Doravirine (MK-1439) (MK-1439-019)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT02089659·16 enrolled

Observational Study1 trial

"Observational Study on Tolerability and Observance of Post-exposure Prophylaxis With Doravirine in HIV Viral Risk"

Completed·IInstitut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba··NCT05761509·226 enrolled

Pregnancy1 trial

Doravirine Dose Optimisation in Pregnancy

Recruiting·UUniversity of Liverpool·Phase 4·NCT05630638·76 enrolled

Tuberculosis1 trial

Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)··NCT04518228·205 enrolled

Phase II1 trial

HIV-1 Infected Patients, Phase II Trial, Dual Combination Doravirine/Raltegravir Open Label

Recruiting·CCentre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida·Phase 2·NCT04513626·150 enrolled

Interaction1 trial

Doravirine, Rifapentine and Isoniazid Interaction

Completed·WWalter K. Kraft·Phase 1·NCT03886701·11 enrolled

Tenofovir Disoproxil Fumarate1 trial

Evaluating the Pharmacokinetics, Safety, and Tolerability of Doravirine (MK-1439) and Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (MK-1439A) in HIV-1-Infected Children and Adolescents

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1/2·NCT03332095·55 enrolled

Efficacy1 trial

Efficacy of Doravirine + Dolutegravir Dual Therapy in the Context of Antiretroviral Therapy Switch

Recruiting·CChelsea and Westminster NHS Foundation Trust·Phase 3·NCT04892654·150 enrolled

ART1 trial

HIV A6 Genome In ART Unsuccessful Patients On DOR

Unknown status·GGamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation··NCT05322083·60 enrolled

Renal Impairment1 trial

A Study Evaluating the Pharmacokinetics of Doravirine (MK-1439) in Participants With Severe Renal Impairment (MK-1439-051)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT02641067·16 enrolled

Tics1 trial

Pharmacokinetics of Plasma Doravirine Once Daily Over 72 Hours Following Drug Intake Cessation in Healthy Volunteers

Completed·CChelsea and Westminster NHS Foundation Trust·Phase 1·NCT03894124·24 enrolled

Pregnant Women1 trial

Single Dose Pharmacokinetics of Doravirine in HIV-infected Pregnant Women

Completed·UUniversity of North Carolina, Chapel Hill·Phase 1·NCT04900974·8 enrolled

Weight Gain1 trial

Explorations Into the Mechanism for INSTI-associated Weight Gain: a Focus on Energy Balance

Completed·UUniversity of Colorado, Denver··NCT04495348·18 enrolled

End Stage Renal Disease (ESRD)1 trial

Removal of Doravirine by Hemodialysis in HIV-Infected Patients With End-stage Renal Disease (ESRD)

Completed·FFundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia·Phase 4·NCT04689737·8 enrolled

Resistance1 trial

HIV Switch Trial in Experienced Patients With Multiple Class Resistance Including NNRTI Resistance

Unknown status·CClinique du Quartier Latin·Phase 4·NCT04334551·40 enrolled

Human Immunodeficiency Virus (HIV)1 trial

A Phase 2 Clinical Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Doravirine and Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate in Participants With HIV-1, Who Are 4 Weeks to Less Than 12 Years of Age and Weigh Less Than 45 kg

Recruiting· Merck & Co. logo

Merck & Co.·Phase 2·NCT04375800·84 enrolled

Regulatory

FDA Approval Timeline[5]

Aug 30, 2018

PIFELTRO

NDA NDA210806

Aug 30, 2018

PIFELTRO

NDA NDA210806

Sep 19, 2019

PIFELTRO

NDA NDA210806

Oct 10, 2019

PIFELTRO

NDA NDA210806

Jan 27, 2022

PIFELTRO

NDA NDA210806

Nov 7, 2024

PIFELTRO

NDA NDA210806

Oct 29, 2025

PIFELTRO

NDA NDA210806

Sources

References

[1]
ClinicalTrials.gov — 26 trial records for Doravirine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Pifeltro drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Doravirine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Doravirine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA210806). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Pifeltro. U.S. Food & Drug Administration.
[7]
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: NNRTI[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Patent Landscape[6]

Patent Cliff

Aug 30, 2032

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8486975Aug 30, 2032

Pifeltro

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2027

Q3 2028

Q2 2034

Trials by Indication[1]

Immunodeficiency4 trials

Concentration2 trials

Tenofovir2 trials

Aged1 trial

Methadone1 trial

Hepatic Insufficiency1 trial

Observational Study1 trial

Pregnancy1 trial

Tuberculosis1 trial

Phase II1 trial

Interaction1 trial

Tenofovir Disoproxil Fumarate1 trial

Efficacy1 trial

ART1 trial

Renal Impairment1 trial

Tics1 trial

Pregnant Women1 trial

Weight Gain1 trial

End Stage Renal Disease (ESRD)1 trial

Resistance1 trial

Human Immunodeficiency Virus (HIV)1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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