Last reviewed · How we verify

AB1010

AB Science · Phase 2 active Small molecule Under review

AB1010 is a PI3K inhibitor Small molecule drug developed by AB Science. It is currently in Phase 2 development for Metastatic breast cancer. Also known as: masitinib.

AB1010 is a small molecule that targets the PI3K pathway.

AB1010, also known as masitinib, is a small molecule inhibitor of the fibroblast growth factor receptor 3. It has been studied in clinical trials for various conditions, including Gastro Intestinal Stromal Tumor, Multiple Sclerosis, Rheumatoid Arthritis, Multiple Myeloma, and Asthma.

Likelihood of approval
13.3% 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).
  • Oncology Phase 2 attrition -2.0pp
    Oncology drugs have higher Phase 2-to-Phase 3 attrition than average — many fail to show OS benefit in larger studies.
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 nameAB1010
Also known asmasitinib
SponsorAB Science
Drug classPI3K inhibitor
TargetPI3K
ModalitySmall molecule
Therapeutic areaOncology
PhasePhase 2

Mechanism of action

AB1010 works by inhibiting the PI3K enzyme, which is involved in cell signaling pathways. This inhibition can lead to the reduction of cancer cell growth and proliferation.

Approved indications

Common side effects

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about AB1010

What is AB1010?

AB1010 is a PI3K inhibitor drug developed by AB Science, indicated for Metastatic breast cancer.

How does AB1010 work?

AB1010 is a small molecule that targets the PI3K pathway.

What is AB1010 used for?

AB1010 is indicated for Metastatic breast cancer.

Who makes AB1010?

AB1010 is developed by AB Science (see full AB Science pipeline at /company/ab-science).

Is AB1010 also known as anything else?

AB1010 is also known as masitinib.

What drug class is AB1010 in?

AB1010 belongs to the PI3K inhibitor class. See all PI3K inhibitor drugs at /class/pi3k-inhibitor.

What development phase is AB1010 in?

AB1010 is in Phase 2.

What are the side effects of AB1010?

Common side effects of AB1010 include Diarrhea, Nausea, Fatigue.

What does AB1010 target?

AB1010 targets PI3K and is a PI3K inhibitor.

Related

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