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single dose Nevirapine
single dose Nevirapine is a Small molecule drug developed by National Institute of Allergy and Infectious Diseases (NIAID). It is currently in Phase 2 development. Also known as: SD NVP.
Nevirapine is a small molecule inhibitor of the human immunodeficiency virus type 1 reverse transcriptase. It is used to treat conditions such as HIV-1-infection, HIV/AIDS, and HIV Infections, including in pregnant individuals.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | single dose Nevirapine |
|---|---|
| Also known as | SD NVP |
| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
- Blood sodium decreased
- Blood calcium decreased
- Blood alkaline phosphatase increased
- Haemoglobin decreased
- Blood bilirubin increased
- Amylase increased
- Blood glucose decreased
- Blood glucose increased
- Blood potassium decreased
- Aspartate aminotransferase increased
- Blood magnesium decreased
- Neutrophil count decreased
Key clinical trials
- A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments (PHASE4)
- Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy
- Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (PHASE2, PHASE3)
- ARVs to Prevent Breastmilk HIV:Viral and Immune Responses (PHASE2)
- Reducing the Incidence of Nevirapine Resistance Mutations in Pregnant HIV Infected Women Who Receive Anti-HIV Drugs Prior to and After Giving Birth (PHASE2)
- Preventing Sexual Transmission of HIV With Anti-HIV Drugs (PHASE3)
- Comparison of Three Anti-HIV Regimens to Prevent Nevirapine Resistance in Women Who Take Nevirapine During Pregnancy (PHASE2)
- The Effect of Phenytoin on the Pharmacokinetics of Nevirapine and the Development of Nevirapine Resistance (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- single dose Nevirapine CI brief — competitive landscape report
- single dose Nevirapine updates RSS · CI watch RSS
- National Institute of Allergy and Infectious Diseases (NIAID) portfolio CI
Frequently asked questions about single dose Nevirapine
What is single dose Nevirapine?
Who makes single dose Nevirapine?
Is single dose Nevirapine also known as anything else?
What development phase is single dose Nevirapine in?
What are the side effects of single dose Nevirapine?
Related
- Manufacturer: National Institute of Allergy and Infectious Diseases (NIAID) — full pipeline
- Also known as: SD NVP
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing