Idarubincin

Affiliated Hospital of Nantong University · Phase 1 active Small molecule

Idarubincin is a Small molecule drug developed by Affiliated Hospital of Nantong University. It is currently in Phase 1 development. Also known as: IDA.

Idarubicin is a medication used to treat Acute Myeloid Leukemia, a type of blood cancer. It has been studied in combination with other treatments, including Amifostine (Ethyol) and Venetoclax, in clinical trials.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

• Baseline phase 1 → approval rate +9.6pp
  Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2033–2036	—
EMA	EU	2034–2037	+0.7 yr
MHRA	GB	2034–2037	+0.7 yr
Health Canada	CA	2034–2038	+0.9 yr
TGA	AU	2034–2038	+1.2 yr
PMDA	JP	2034–2038	+1.5 yr
NMPA	CN	2035–2039	+2.3 yr
MFDS	KR	2034–2038	+1.4 yr
CDSCO	IN	2034–2039	+1.8 yr
ANVISA	BR	2035–2039	+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	Idarubincin
Also known as	IDA
Sponsor	Affiliated Hospital of Nantong University
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

• Venetoclax Combined with Intensive Therapy for Acute Myeloid Leukemia Patients with Lower Early Peripheral Blast Clearance Rate After Standard Induction Therapy (NA)
• Study Evaluating the Addition of Amifostine (Ethyol®) to Idarubicin and Cytosine Arabinoside in Older Patients With Acute Myeloid Leukemia (PHASE1, 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:

• Idarubincin CI brief — competitive landscape report
• Idarubincin updates RSS · CI watch RSS
• Affiliated Hospital of Nantong University portfolio CI

Frequently asked questions about Idarubincin

What is Idarubincin?

Idarubincin is a Small molecule drug developed by Affiliated Hospital of Nantong University.

Who makes Idarubincin?

Idarubincin is developed by Affiliated Hospital of Nantong University (see full Affiliated Hospital of Nantong University pipeline at /company/affiliated-hospital-of-nantong-university).

Is Idarubincin also known as anything else?

Idarubincin is also known as IDA.

What development phase is Idarubincin in?

Idarubincin is in Phase 1.

Related

• Manufacturer: Affiliated Hospital of Nantong University — full pipeline
• Therapeutic area: All drugs in Other
• Also known as: IDA