Viramune

(Nevirapine)

ApprovedSmall molecule

Nevirapine is used to treat HIV infection by helping to slow down the virus's ability to reproduce in the body, usually as part of a combination treatment with other HIV medications.[2] Viramune is currently approved and in use across 7 indications[4].[1]

Viramune is one of 231 small molecule programs targeting AIDS. It is currently in Approved.

Indications

123

Total Trials

Active Trials

230

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

AIDSApproved

HIV InfectionCompleted

Viral DiseaseActive, not recruiting

HIV-1 InfectionActive, not recruiting

ImmunodeficiencyCompleted

TuberculosisCompleted

TreatmentCompleted

AIDSApproved

Approved

HIV InfectionApproved

Completed

Viral DiseaseApproved

Active, not recruiting

HIV-1 InfectionApproved

Active, not recruiting

ImmunodeficiencyApproved

Completed

TuberculosisApproved

Completed

TreatmentApproved

Completed

Competition

Competitive Landscape

332 competitors in Treatment

#DrugCompanyPhaseTrials

Viramune

Boehringer Ingelheim

Approved

6 2

Dexilant

Takeda

Preclinical

2 3

Alfenta

Jazz Pharmaceuticals

Preclinical

1 4

Niclocide

Bayer

Preclinical

1 5

Hivid

CConrado Roberto Hoffmann Filho

Preclinical

6 6

Valium

Akero Therapeutics

Preclinical

2 7

Clomid

Ferring

Preclinical

1 8

Aurlumyn

BBTG International Inc.

Preclinical

1 9

Lotemax

PPharmos

Preclinical

1 10

Norpramin

VValidus Pharmaceuticals

Preclinical

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

Timeline

Expected Milestones

Q2 2029

Phase 2/3Active, not recruiting

Treatment

NCT02369406

Q4 2031

PreclinicalRecruiting

HIV Infection

NCT02140255

Clinical

Trials by Indication[1]

HIV infection11 trials

Evaluating Strategies to Reduce Mother-to-Child Transmission of HIV Infection in Resource-Limited Countries

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT01061151·3,747 enrolled

Comparison of Three Different Initial Treatments Without Protease Inhibitors for HIV Infection

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00013520·1,125 enrolled

HIV Infection And Metabolic Abnormalities Protocol 1 (HAMA001)

Completed·KKirby Institute·Phase 4·NCT00192660·80 enrolled

Show 8 more trials

A Study to Learn More About MAC Disease and the Use of Anti-HIV Drugs in Patients With Advanced HIV Infection

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00000895·85 enrolled

Treatment With Combinations of Several Antiviral Drugs in Infants and Young Children With HIV Infection

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000872·55 enrolled

Use of Combined Antiretroviral Therapy to Determine Sites of Persistent HIV Infection

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00001644·42 enrolled

The Safety and Effectiveness of Retrovir Plus HIVID Combined With Either Nevirapine or Invirase in the Treatment of HIV Infection

Completed·PParexel·Phase 2·NCT00002347·225 enrolled

Combination Treatment With and Without Protease Inhibitors for Women Who Begin Therapy for HIV Infection During Pregnancy

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00017719·440 enrolled

An Open-Label, Staggered Rising Dose Cohort Study Assessing the Pharmacokinetics, Safety, and Tolerance of BI-RG-587 in Combination With Zidovudine in Patients With HIV Infection (CD4+ Cell Count < 400/mm3)

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT00000649·30 enrolled

Anti-HIV Drugs for Treating Infants Who Acquired HIV Infection at Birth

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00102960·377 enrolled

Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission: A Phase I/II Proof of Concept Study

Recruiting·NNational Institute of Allergy and Infectious Diseases (NIAID)·Preclinical·NCT02140255·1,120 enrolled

Effectiveness10 trials

The Safety and Effectiveness of Nevirapine and Zidovudine, Given Separately and Together, in HIV-1 Infected Patients Who Have No Symptoms of the Disease

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 2·NCT00002324·250 enrolled

A Study to Evaluate the Long-Term Effectiveness of Three Anti-HIV Drug Regimens in HIV Infected Patients Who Have Never Been Exposed to Highly Active Antiretroviral Therapy (HAART)

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00000922·1,710 enrolled

The Safety and Effectiveness of Nevirapine Plus Lamivudine Plus Other Anti-HIV Drugs

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT00002368·2,000 enrolled

Show 7 more trials

The Safety and Effectiveness of BI-RG-587 in HIV-Infected Patients

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000962·30 enrolled

A Study to Compare the Effectiveness of a Four Drug Anti-HIV Regimen Given Alone or in Combination With GM-CSF or IL-12 to HIV-Positive Patients

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00000896·24 enrolled

The Safety and Effectiveness of Nevirapine Plus Nelfinavir in HIV-1 Infected Patients Who Have Taken Stavudine

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT00002381·24 enrolled

Effectiveness of AZT and Nevirapine in Preventing HIV Transmission From Ugandan Mothers to Their Newborns

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00006396·1,500 enrolled

A Study of the Safety and Effectiveness of Treating Advanced AIDS Patients Between Ages 4 and 22 With 7 Drugs, Some at Higher Than Usual Doses

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00001108·6 enrolled

Safety and Effectiveness of Four Anti-HIV Drug Combinations in HIV-Infected Children and Teens

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00001091·200 enrolled

The Safety and Effectiveness of Didanosine Plus Stavudine Plus Nevirapine Combined With MKC-442 in HIV-Infected Patients Who Have Not Had Success With Protease Inhibitors

Terminated· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT00002418·25 enrolled

Children9 trials

A Study of Nevirapine Used Alone or in Combination With AZT in HIV-1-Infected Children

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00001111·35 enrolled

When to Start Anti-HIV Drugs in Children Infected With HIV (The PREDICT Study)

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00234091·300 enrolled

Population Pharmacokinetics of Antiretroviral in Children

Completed·AAssistance Publique - Hôpitaux de Paris··NCT03194165·65 enrolled

Show 6 more trials

Comparison of New Anti-HIV Drug Combinations in HIV-Infected Children Who Have Taken Anti-HIV Drugs

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00001083·240 enrolled

Safety and Pharmacokinetic Study of Fixed Dose Combination of Zidovudine, Lamivudine, and Nevirapine in HIV-Infected Children in Thailand

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1/2·NCT00672412·42 enrolled

A Pilot Pharmacokinetic Phase I Evaluation of BI-RG-587 in HIV-Infected Children

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00000634·6 enrolled

Drug Levels of Tablet and Liquid Forms of Lamivudine, Nevirapine, and Stavudine in HIV Infected Thai Children

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1/2·NCT00312091·44 enrolled

Blood Levels of Anti-HIV Drugs Used in Combination Regimens in HIV Infected Children

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1/2·NCT00260078·75 enrolled

A Phase I Multiple Dose Pharmacokinetic Study of Nevirapine Extended Release (XR) in HIV-1 Infected Children.

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT00905489·85 enrolled

Drug6 trials

Study to Determine the Pharmacokinetic Behavior of Antiretroviral Drugs in Patients Infected by HIV

Completed·GGermans Trias i Pujol Hospital·Phase 1·NCT00307502·675 enrolled

A Study of Three Anti-HIV Drug Combinations in Patients Who Have Taken Amprenavir

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00001095·94 enrolled

A Study of Three Drug Combination Therapies in HIV-Infected Patients Who Have Never Been Treated With Anti-HIV Drugs

Completed·WWeill Medical College of Cornell University·N/A·NCT00002407

Show 3 more trials

A Study to Compare Two Different Anti-HIV Drug Regimens

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000924·120 enrolled

Comparison of Three Anti-HIV Drug Combinations in HIV-Infected Patients With No Symptoms of the Disease

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00001045·300 enrolled

Preventing Sexual Transmission of HIV With Anti-HIV Drugs

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00074581·3,526 enrolled

Treatment6 trials

Evaluation of Two Anti-HIV Treatment Strategies in Resource-Limited South African Communities

Completed·CCIPRA SA·N/A·NCT00255840·812 enrolled

Effects of Treatment Changes on Fat Wasting in the Arms and Legs of HIV Patients

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00028314·150 enrolled

A Study to Compare Two Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Previously Received Anti-HIV Treatment

Completed·AAbbott·Phase 3·NCT00004581·300 enrolled

Show 3 more trials

Early Infant HIV Treatment in Botswana

Active, not recruiting·HHarvard School of Public Health (HSPH)·Phase 2/3·NCT02369406·67 enrolled

Study to Evaluate the Replacement of Reverse Transcriptase Nucleoside/Nucleotide Inhibitors by Nevirapine in Patients on Triple Treatment With Analogues Only

Completed·—·Phase 4·NCT00415090·28 enrolled

Open Label Study of NVP+CBV Treatment in Women Who Have Received sdNVP for the pMTCT of HIV

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 4·NCT00144157·53 enrolled

51 more indications

Prevention5 trials

Prevention of Milk-Borne Transmission of HIV-1C in Botswana

Completed·HHarvard School of Public Health (HSPH)·N/A·NCT00197587·1,200 enrolled

A Study of Nevirapine for the Prevention of HIV Transmission From Mothers to Their Babies

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00000869·2,009 enrolled

Trial of Three Neonatal Antiretroviral Regimens for Prevention of Intrapartum HIV Transmission

Completed·EEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)·Phase 3·NCT00099359·1,735 enrolled

Show 2 more trials

Trizivir Vs. Kaletra and Combivir for the Prevention of Mother-to-Child Transmission of HIV

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00270296·730 enrolled

Nevirapine Study for the Prevention of Maternal-Infant HIV Transmission in Uganda

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00639938·722 enrolled

HIV5 trials

Daily Nevirapine to Prevent Mother to Infant Transmission of HIV

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00061321·770 enrolled

Efavirenz-based Versus Nevirapine-based Antiretroviral Therapy Among HIV-infected Patients Receiving Rifampin

Completed·BBamrasnaradura Infectious Diseases Institute·Phase 3·NCT00483054·142 enrolled

A Study of ABT-378/Ritonavir Combination in HIV-Infected Patients Who Have Taken Protease Inhibitors

Completed·AAbbott·Phase 1·NCT00004580

Show 2 more trials

Study to Evaluate the Influence of Nevirapine to Atazanavir in Steady State Equilibrium in HIV Patients

Completed·GGermans Trias i Pujol Hospital·Phase 4·NCT00355719·14 enrolled

A Study of Nevirapine to Prevent HIV Transmission From Mothers to Their Babies

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00000942·1,244 enrolled

Interaction5 trials

ATV/Ritonavir Nevirapine Interaction (USPAC)

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT00162149·46 enrolled

Pharmacokinetic Study of Interaction Between Nevirapine and Methadone in HIV-1 Infected, Opioid-dependent Adults

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 4·NCT00273988·10 enrolled

Investigation of the Potential Pharmacokinetic Interaction Between Nevirapine, Abacavir and Amprenavir in HIV-1 Infected Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) Naive Adults

Terminated· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02182765·8 enrolled

Show 2 more trials

Pharmacokinetic Interaction Between Nevirapine and Saquinavir-sgc in HIV-1 Infected Patients

Terminated· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02184286·5 enrolled

Investigation of the Potential Pharmacokinetic Interaction Between Nevirapine (VIRAMUNE) and Ethinyl Estradiol/Norethindrone in HIV-1 Infected Women

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02182791·14 enrolled

Double-blind3 trials

A Randomized, Double-Blind, Four-Arm Study Comparing Combination Nucleoside, Alternating Nucleoside, and Triple-Drug Therapy for the Treatment of Advanced HIV Disease (CD4 <= 50/mm3)

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000781·1,292 enrolled

A Comparative Study of a Combination of Zidovudine, Didanosine, and Double-Blinded Nevirapine Versus a Combination of Zidovudine and Didanosine

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000770·400 enrolled

A Multi-Center, Placebo-Controlled, Double-Blind, Randomized Trial Comparing the Virologic and Immunologic Activities of 400 Mg Nevirapine in Combination With Zidovudine Versus Zidovudine Alone in Asymptomatic HIV-1 Infected Patients With 4-12 Months of Prior Zidovudine Therapy and 200-500 CD4+ Cell

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·N/A·NCT00002323·60 enrolled

Tics3 trials

An Open-Label Study in HIV+ Patients to Determine the Effects of Nevirapine (Viramune) on the Pharmacokinetics of Clarithromycin and Activity of Cytochrome 3A4.

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT00002194·36 enrolled

Study to Determine the Effects of Nevirapine (VIRAMUNE®) on the Steady State Pharmacokinetics of Rifabutin (MYCOBUTIN®) in HIV+ Patients

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 4·NCT02184078·19 enrolled

Effects of Nevirapine on the Steady State Pharmacokinetics of Fluconazole in HIV Positive Patients

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 4·NCT02181946·24 enrolled

Resistance3 trials

Pharmacokinetics Study on Nevirapine Resistance in Tanzania

Completed·RRadboud University Medical Center·Phase 2·NCT00294892·144 enrolled

Pediatric Nevirapine Resistance Study

Unknown status·EEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)·Phase 3·NCT00117728·250 enrolled

Reducing the Incidence of Nevirapine Resistance Mutations in Pregnant HIV Infected Women Who Receive Anti-HIV Drugs Prior to and After Giving Birth

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00109590·175 enrolled

Side Effects2 trials

Changing to Nonprotease Inhibitor Treatment to Improve Side Effects

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00021463·342 enrolled

Neuropsychiatric Side Effects of Efavirenz in Children Living With HIV

Completed·RRadboud University Medical Center··NCT03227653·144 enrolled

Pilot Study2 trials

A Pilot Study of the Immunologic Reconstitution in HIV-1 Infected Children Receiving Highly Active Antiretroviral Therapy With Combination Ritonavir, Nevirapine and Stavudine

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00001688·25 enrolled

An Open-Label, Pilot Study to Evaluate the Development of Resistance to Nevirapine (BI-RG-587) in HIV-Infected Patients With CD4 Cell Count >= 500/mm3

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000747·10 enrolled

Pregnancy2 trials

A Study to Evaluate the Effects of Genetic Factors on the Pharmacokinetics of Antiretroviral Drugs During Pregnancy and Lactation

Completed·AAdeniyi Olagunju··NCT02269462·460 enrolled

Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)··NCT00042289·1,578 enrolled

Efficacy2 trials

Efficacy of Rilpivirine-based Regimens as Switch Therapy From Nevirapine-based Regimens in HIV-infected Patients

Completed·MMahidol University·N/A·NCT03664440·106 enrolled

Efficacy of Nevirapine Compared to ZDV + 3TC Administered in Labor and Again at Postdelivery in HIV Positive Women

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT02181933·2,648 enrolled

Efficacy and Safety2 trials

Trial to Evaluate Steady State Pharmacokinetic Parameters, Efficacy and Safety of Nevirapine in Antiretroviral Drug naïve Pediatric Patients

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 2·NCT00273975·123 enrolled

Efficacy and Safety of Concomitant Use of Nevirapine and Rifampicin With HIV-TB

Completed·—·Phase 3·NCT01805258·135 enrolled

Malaria2 trials

Differences in Malaria Infection Levels in HIV-infected Infants and Children Receiving PI- and NNRTI-based HAART

Completed·IInternational Maternal Pediatric Adolescent AIDS Clinical Trials Group·Phase 1·NCT00719602·105 enrolled

HIV Protease Inhibitors for the Prevention of Malaria in Ugandan Children

Completed·UUniversity of California, San Francisco·Phase 3·NCT00978068·176 enrolled

Single Dose2 trials

A Study of Single Dose Nevirapine (NVP) Combined With Combivir® for the Prevention of Mother to Child Transmission (pMTCT) - Treatment Options Preservation Study (TOPS)

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT00144183·407 enrolled

Antiviral Responses to NNRTI-Based vs. PI-Based ARV Therapy in HIV Infected Infants Who Have or Have Not Received Single Dose NVP for Prevention of Mother-to-Child Transmission of HIV

Completed·IInternational Maternal Pediatric Adolescent AIDS Clinical Trials Group·Phase 2·NCT00307151·452 enrolled

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 4·NCT00274001·158 enrolled

Medication1 trial

Three Month Course of Anti-HIV Medications for People Recently Infected With HIV

Withdrawn·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00087464

Antiretroviral Treatment1 trial

Trial About Hepatic Security of Antiretroviral Treatment Based on Kaletra Versus Nevirapine in Co-infected HIV/HCV Patients

Terminated·GGermans Trias i Pujol Hospital·Phase 4·NCT00661349·9 enrolled

Adult1 trial

Nevirapine vs Ritonavir-boosted Lopinavir in ART Naive HIV-infected Adults in a Resource Limited Setting

Completed·—·Phase 4·NCT01772940·425 enrolled

Drug Therapy1 trial

A Study on the Management of Combination Anti-HIV Drug Therapy in HIV-Positive Children With Prior Treatment

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000902·217 enrolled

Impaired Renal Function1 trial

Evaluation of Renal Function, Efficacy, and Safety When Switching From Tenofovir/Emtricitabine Plus a Protease Inhibitor/Ritonavir, to a Combination of Raltegravir (MK-0518) Plus Nevirapine Plus Lamivudine in HIV-1 Participants With Suppressed Viremia and Impaired Renal Function (MK-0518-284)

Terminated· Merck & Co. logo

Merck & Co.·Phase 2·NCT02116660·11 enrolled

Infants1 trial

A Study of Nevirapine to Prevent HIV Transmission From Mothers to Their Infants

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00001135·2,009 enrolled

Plasmodium Falciparum1 trial

Comparing PI-Based to a nNRTI-based ART for Clearance of Plasmodium Falciparum Parasitemia in HIV-Infected

Completed·AAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections·Phase 1/2·NCT01632891·52 enrolled

HCV1 trial

Influence of Nevirapine on HCV Viral Load

Unknown status·VValme University Hospital·N/A·NCT01277627·60 enrolled

Immune System1 trial

Effects of Two Anti-HIV Drug Combinations on the Immune Systems of HIV-Infected Patients Who Have Never Received Anti-HIV Drugs

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00004855·55 enrolled

Clinical Trial1 trial

Latency and Early Neonatal Provision of Antiretroviral Drugs Clinical Trial

Completed·—·Phase 4·NCT02431975·73 enrolled

Neurocognitive Function1 trial

The CogNaive Study: Assessing Changes in Neurocognitive Function in Treatment Naïve HIV-1 Positive Subjects

Completed·IImperial College London·Phase 4·NCT00540137·21 enrolled

Women1 trial

NNRTI vs PI Regimens for HIV Infected Women After They Have Taken Nevirapine to Prevent Mother-To-Child HIV Transmission

Completed·AAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections·Phase 3·NCT00089505·745 enrolled

Pregnant Women1 trial

A Phase I Study of Safety and Pharmacokinetics of Nevirapine in HIV-1 Infected Pregnant Women and Neonates Born to HIV-1 Infected Mothers

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000808·49 enrolled

Hepatic Function1 trial

A Pharmacokinetic Study to Assess Nevirapine [Viramune] Levels in HIV Infected Patients With Impaired Hepatic Functions

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 4·NCT00144248·51 enrolled

Function1 trial

Study to Evaluate the Effects of Underlying Renal or Hepatic Dysfunction on the Pharmacokinetics of Nevirapine

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02184091·41 enrolled

Progesterone1 trial

Depo-Medroxyprogesterone Acetate (DMPA, Depo-Provera) Use With Certain Anti-HIV Drugs in HIV-Infected Women

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00016601·76 enrolled

Newborns1 trial

Antiretroviral Regime for Viral Eradication in Newborns

Completed·NNational Center for Women and Children's Health, China CDC·Phase 4·NCT02712801·600 enrolled

Long-term Follow-up1 trial

2NN & CHARM Long-Term Follow-up Study

Completed·IInternational Antiviral Therapy Evaluation Center·Phase 4·NCT00127972·763 enrolled

Prophylaxis1 trial

Extended Infant Post-exposure Prophylaxis With Antiretrovirals to Reduce Postnatal HIV Transmission

Completed·JJohns Hopkins Bloomberg School of Public Health·Phase 3·NCT00115648·3,300 enrolled

Absorption1 trial

Pharmacoscintigraphic Investigation Into the Absorption of Nevirapine When Released Into Different Parts of the Gastro-intestinal Tract in Healthy Males

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02191189·27 enrolled

Oral1 trial

Relative Bioavailability of Different Oral Viramune Extended Release Formulations Compared to Viramune® Oral Suspension in Healthy Male Volunteers

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02192463·204 enrolled

Infection1 trial

Clinical and Therapeutic Evaluation of the Infection by HIV/AIDS

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim··NCT02191215·442 enrolled

Moringa Oleifera1 trial

Moringa Oleifera- Antiretroviral Pharmacokinetic Drug Interaction

Completed·UUniversity of Zimbabwe··NCT01410058·19 enrolled

Age1 trial

Pharmacokinetic Properties of Two Dosages Nevirapine Extended Release (XR) Formulations Compared to VIRAMUNE® Tablet as Well as to Nevirapine XR Tablet in Healthy Male Volunteers

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02184312·96 enrolled

Child1 trial

Nevirapine (NVP) Use to Prevent Mother-to-Child Transmission of HIV

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00074399·775 enrolled

Randomized1 trial

An Open-label, Non-randomized, Single-arm Study to Investigate the Mechanism(s) by Which Nevirapine Increases Plasma HDL in HIV+ Subjects

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 4·NCT00144261·15 enrolled

Pregnant Woman1 trial

Study of HIV-Infected and Uninfected Pregnant Woman/Child Dyads in Gaborone, Botswana

Completed·—·Phase 4·NCT03088410·495 enrolled

Tuberculosis1 trial

Optimal Dosing of 1st Line Antituberculosis and Antiretroviral Drugs in Children (a Pharmacokinetic Study)

Completed·UUniversity of Cape Town·Phase 4·NCT01637558·200 enrolled

Tenofovir1 trial

Zidovudine / Lamivudine + Nevirapine Twice Daily, Versus Tenofovir + Lamivudine + Nevirapine Once Daily in ARV-Naive Patients

Unknown status·MMEDEX·Phase 3·NCT00199979·250 enrolled

Immunodeficiency1 trial

Study of Nevirapine and Prednisone to Determine the Safety and Effectiveness in Preventing Nevirapine Associated Rash in Human Immunodeficiency Virus (HIV) Infected Patients

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 4·NCT02184299·138 enrolled

Breast1 trial

The Safety of Nevirapine When Given to Breast-Feeding Babies From Birth to Age 6 Months

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00006279·75 enrolled

Dyslipidemia1 trial

Efavirenz to Nevirapine Switch and Low-Density Lipoprotein (LDL)-Dyslipidemia

Completed·UUniversity Hospital, Caen·Phase 4·NCT00405171·40 enrolled

Pediatric Patients1 trial

An Open-Label, Non-Randomized Trial to Evaluate the Tolerability and Safety of Viramune (Nevirapine) in Adult and Pediatric Patients With Progressive HIV Disease

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT00002166

Unspecified6 trials

Pharmacokinetic Evaluation of Changes in Nevirapine AUC Due to Differences in Weight

Completed·WWestern University of Health Sciences··NCT01335360·21 enrolled

VENICE Study Nevirapine Full Dose/Dose Escalation

Completed·CClinical Trial Agency of HIV Study Group·Phase 4·NCT00704249·80 enrolled

A Pharmacokinetic Evaluation of Levonorgestrel Implant and Antiretroviral Therapy

Completed·UUniversity of Nebraska·Phase 2·NCT01789879·60 enrolled

Show 3 more trials

Case-Control Viramune (Nevirapine) Toxicogenomics Study

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim··NCT00310843·889 enrolled

Multiple Dose BE Study With Nevirapine 400mg PR Tablets

Completed·RRatiopharm GmbH·Phase 1·NCT02202005·46 enrolled

Durability of Nevirapine-Based Antiretroviral Regimen

Completed·BBamrasnaradura Infectious Diseases Institute·Phase 4·NCT00703898·140 enrolled

Regulatory

FDA Approval Timeline[5]

Jun 21, 1996

VIRAMUNE

NDA NDA020636

Sep 11, 1998

VIRAMUNE

NDA NDA020933

Nov 8, 2012

VIRAMUNE XR

NDA NDA201152

Sources

References

[1]
ClinicalTrials.gov — 123 trial records for Nevirapine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Viramune drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Nevirapine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Nevirapine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA201152). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Viramune. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Boehringer Ingelheim company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Human Immunodeficiency Virus Type 1 Reverse Transcriptase Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Boehringer Ingelheim

Patent Landscape[6]

Patent Cliff

Mar 12, 2029

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8460704Mar 12, 2029

Viramune

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q2 2029

Q4 2031

Trials by Indication[1]

HIV infection11 trials

Effectiveness10 trials

Children9 trials

Drug6 trials

Treatment6 trials

Prevention5 trials

HIV5 trials

Interaction5 trials

Double-blind3 trials

Tics3 trials

Resistance3 trials

Side Effects2 trials

Pilot Study2 trials

Pregnancy2 trials

Efficacy2 trials

Efficacy and Safety2 trials

Malaria2 trials

Single Dose2 trials

Chorioamnionitis1 trial

Adolescent1 trial

Breastfeeding1 trial

Quality of Life1 trial

Medication1 trial

Antiretroviral Treatment1 trial

Adult1 trial

Drug Therapy1 trial

Impaired Renal Function1 trial

Infants1 trial

Plasmodium Falciparum1 trial

HCV1 trial

Immune System1 trial

Clinical Trial1 trial

Neurocognitive Function1 trial

Women1 trial

Pregnant Women1 trial

Hepatic Function1 trial

Function1 trial

Progesterone1 trial

Newborns1 trial

Long-term Follow-up1 trial

Prophylaxis1 trial

Absorption1 trial

Oral1 trial

Infection1 trial

Moringa Oleifera1 trial

Age1 trial

Child1 trial

Randomized1 trial

Pregnant Woman1 trial

Tuberculosis1 trial

Tenofovir1 trial

Immunodeficiency1 trial

Breast1 trial

Dyslipidemia1 trial

Pediatric Patients1 trial

Unspecified6 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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