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2',3'-dideoxyinosine
2',3'-dideoxyinosine is a Nucleoside reverse transcriptase inhibitor (NRTI) Small molecule drug developed by National Cancer Institute (NCI). It is currently in Phase 3 development for HIV-1 infection.
2',3'-dideoxyinosine (ddI) is a nucleoside reverse transcriptase inhibitor that blocks HIV replication by inhibiting the enzyme responsible for converting viral RNA into DNA.
2',3'-dideoxyinosine (ddI) is a nucleoside reverse transcriptase inhibitor that blocks HIV replication by inhibiting the enzyme responsible for converting viral RNA into DNA. Used for HIV-1 infection.
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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). -
Anti-infectives pathway favourability
+2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.
| 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 | 2',3'-dideoxyinosine |
|---|---|
| Sponsor | National Cancer Institute (NCI) |
| Drug class | Nucleoside reverse transcriptase inhibitor (NRTI) |
| Target | HIV reverse transcriptase |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Virology |
| Phase | Phase 3 |
Mechanism of action
ddI is a purine nucleoside analog that is phosphorylated intracellularly to its active form, ddATP, which competitively inhibits HIV reverse transcriptase and causes chain termination during viral DNA synthesis. This prevents the virus from integrating its genetic material into the host cell genome and replicating. It was one of the early antiretroviral agents developed for HIV treatment.
Approved indications
- HIV-1 infection
Common side effects
- Pancreatitis
- Peripheral neuropathy
- Diarrhea
- Nausea
- Hepatotoxicity
- Lactic acidosis
Key clinical trials
- Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIV (PHASE2, PHASE3)
- Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy
- IMPAACT 1077HS: Examining Benefits of HAART Continuation in Postpartum Women (PHASE4)
- Reducing the Incidence of Nevirapine Resistance Mutations in Pregnant HIV Infected Women Who Receive Anti-HIV Drugs Prior to and After Giving Birth (PHASE2)
- Safety and Effectiveness of Emtricitabine, Efavirenz, and Didanosine in HIV Infected Children Who Have Taken Few or No Anti-HIV Drugs (PHASE1, PHASE2)
- A Phase I Safety, Efficacy, and Pharmacokinetic Study of 2',3'-Dideoxyinosine (ddI) Administered Twice Daily to Patients With AIDS or AIDS Related Complex (PHASE1)
- Comparison of Three Anti-HIV Drug Combinations in HIV-Infected Patients With No Symptoms of the Disease (PHASE2)
- A Comparison of Three Treatments for Advanced HIV Disease in Patients Who Have Received Nucleoside Therapy in the Past (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:
- 2',3'-dideoxyinosine CI brief — competitive landscape report
- 2',3'-dideoxyinosine updates RSS · CI watch RSS
- National Cancer Institute (NCI) portfolio CI
Frequently asked questions about 2',3'-dideoxyinosine
What is 2',3'-dideoxyinosine?
How does 2',3'-dideoxyinosine work?
What is 2',3'-dideoxyinosine used for?
Who makes 2',3'-dideoxyinosine?
What drug class is 2',3'-dideoxyinosine in?
What development phase is 2',3'-dideoxyinosine in?
What are the side effects of 2',3'-dideoxyinosine?
What does 2',3'-dideoxyinosine target?
Related
- Drug class: All Nucleoside reverse transcriptase inhibitor (NRTI) drugs
- Target: All drugs targeting HIV reverse transcriptase
- Manufacturer: National Cancer Institute (NCI) — full pipeline
- Therapeutic area: All drugs in Infectious Disease / Virology
- Indication: Drugs for HIV-1 infection
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing