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tenofovir monotherapy
tenofovir monotherapy is a Nucleotide reverse transcriptase inhibitor (NtRTI) Small molecule drug developed by Uijeongbu St. Mary Hospital. It is currently in Phase 3 development.
Tenofovir inhibits HIV reverse transcriptase by competing with natural substrates and causing DNA chain termination.
Tenofovir is a small molecule inhibitor that targets human immunodeficiency virus type 1 reverse transcriptase. It has been studied as a treatment for Hepatitis B and Chronic Hepatitis B in clinical trials, including a Phase 3b study comparing its efficacy to emtricitabine/tenofovir.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | tenofovir monotherapy |
|---|---|
| Sponsor | Uijeongbu St. Mary Hospital |
| Drug class | Nucleotide reverse transcriptase inhibitor (NtRTI) |
| Modality | Small molecule |
| Phase | Phase 3 |
Mechanism of action
Tenofovir disoproxil fumarate is converted to tenofovir diphosphate, an active metabolite that competes with deoxyadenosine 5'-triphosphate for incorporation into viral DNA. Once incorporated, it terminates the DNA chain, preventing HIV replication.
Approved indications
Common side effects
Key clinical trials
- A Phase III Study to Evaluate the Efficacy and Safety of ZM-H1505R in Patients With CHB (PHASE3)
- Real-world Study Evaluating the Long-term Outcomes of Pegylated Interferon α-2b Treatment in the Families With Clusters of HBV Infection and Unfavorable Prognosis - A Prospective, Controlled, Multicenter, Cohort Study
- Peginterferon Treatment Study for Inactive Chronic Hepatitis B Patients (PHASE4)
- The Incidence of Hepatitis B in Diffuse Large B-Cell Lymphoma/Chronic Lymphoid Leukemia HBsAg-positive Treated With Rituximab, Chemotherapy and Tenofovir Alafenamide (PHASE2)
- A Clinical Study of TQA3605 Tablets Monotherapy or in Combination With Nucleoside (Acid) Analogues in Treatment Naive and Treated Patients With Chronic Hepatitis B (PHASE1, PHASE2)
- Pegylated Interferon α in Previously Interferon-treated CHB（Leading Study） (NA)
- HBsAg Seroclearance in Adults With HBV Related Liver Fibrosis After Receiving Combined Therapy of Peg-IFN and Tenofovir. (PHASE4)
- Real-world Study Optimizing Nucleotide-analogues
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:
- tenofovir monotherapy CI brief — competitive landscape report
- tenofovir monotherapy updates RSS · CI watch RSS
- Uijeongbu St. Mary Hospital portfolio CI
Frequently asked questions about tenofovir monotherapy
What is tenofovir monotherapy?
How does tenofovir monotherapy work?
Who makes tenofovir monotherapy?
What drug class is tenofovir monotherapy in?
What development phase is tenofovir monotherapy in?
Related
- Drug class: All Nucleotide reverse transcriptase inhibitor (NtRTI) drugs
- Manufacturer: Uijeongbu St. Mary Hospital — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing