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Isoprinosine
Isoprinosine is a Small molecule drug developed by Ain Shams University. It is currently in Phase 3 development.
Isoprinosine is a small molecule antiviral drug used to treat various conditions, including HIV infections, lymphatic disease, and respiratory tract infections. It is a combination of inosine and dimepranol acedoben in a ratio of 1 to 3, and is primarily used in European countries to treat acute viral infections.
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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 | Isoprinosine |
|---|---|
| Sponsor | Ain Shams University |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- Levamisole and Isoprinosine in the Treatment of COVID19: A Proposed Therapeutic Trial (PHASE3)
- Levamisole and Isoprinosine in Immune-prophylaxis of Egyptian Healthcare Workers Facing COVID-19 (PHASE3)
- Isoprinosine in HIV Patients With Viral Load > 50 y < 200 Copies/mL (PHASE4)
- A Phase I/II Trial of Ribavirin (With Escalation) + Isoprinosine in Asymptomatic HIV-Viremic Patients (PHASE1)
- A Multi-Center Randomized Double-Blind Placebo-Controlled Study To Investigate the Effect of Isoprinosine in Immunodepressed Patients With Uncomplicated Generalized Lymphadenopathy (NA)
- A Study of Isoprinosine in Patients With Severe AIDS (NA)
- A Study of Isoprinosine in Patients With Lymph Node Disease (NA)
- The Safety and Effectiveness of Isoprinosine in Patients With Weakened Immune Systems and Lymph Node Disease (NA)
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:
- Isoprinosine CI brief — competitive landscape report
- Isoprinosine updates RSS · CI watch RSS
- Ain Shams University portfolio CI
Frequently asked questions about Isoprinosine
What is Isoprinosine?
Who makes Isoprinosine?
What development phase is Isoprinosine in?
Related
- Manufacturer: Ain Shams University — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing