Last reviewed 2026-06-02 · How we verify

Iododeoxycytidine (IBACITABINE)

Phase 2 active Small molecule ✓ Verified Jun 2026

Iododeoxycytidine (generic name: IBACITABINE) is a ibacitabine drug. It is currently in Phase 2 development.

IBACITABINE works by incorporating into DNA and interfering with viral replication.

Iododeoxycytidine is a small molecule with synonyms including IBACITABINA, IBACITABINE, and IBACITABINE, and NSC-527083.

Likelihood of approval

17.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

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).
Anti-infectives pathway favourability +2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.

Predicted approval windows by jurisdiction (conditional on FDA approval)

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	IBACITABINE
Drug class	ibacitabine
Modality	Small molecule
Therapeutic area	Infectious Disease
Phase	Phase 2

Mechanism of action

Imagine your DNA as a blueprint for your body. IBACITABINE is a small molecule that can sneak into this blueprint and disrupt the instructions for making viruses, effectively stopping them from replicating and causing harm.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Iododeoxycytidine CI brief — competitive landscape report
Iododeoxycytidine updates RSS · CI watch RSS

Frequently asked questions about Iododeoxycytidine

What is Iododeoxycytidine?

Iododeoxycytidine (IBACITABINE) is a ibacitabine drug.

How does Iododeoxycytidine work?

IBACITABINE works by incorporating into DNA and interfering with viral replication.

What is the generic name of Iododeoxycytidine?

IBACITABINE is the generic (nonproprietary) name of Iododeoxycytidine.

What drug class is Iododeoxycytidine in?

Iododeoxycytidine belongs to the ibacitabine class. See all ibacitabine drugs at /class/ibacitabine.

What development phase is Iododeoxycytidine in?

Iododeoxycytidine is in Phase 2.

Drug class: All ibacitabine drugs
Therapeutic area: All drugs in Infectious Disease

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing