Dashboard PDUFA PDUFA History Dilution Watch Downside Radar Missed Milestones Earnings Big Movers Blog

🎤 Upcoming Biotech Conferences

Loading conferences...

Free to browse, no account needed Follow the companies behind these drugs with free AI briefings, catalyst countdowns and dilution alerts.

Start 7-day free trial → Log in

IAM1363

Small molecule · Inhibitor of HER2 (ErbB2) receptor tyrosine kinase (ERBB2) · developed by Iambic Therapeutics

Phase 1 Most advanced trial

IAM Developer

1 Registered trials

What is IAM1363?

IAM1363 is an orally administered small molecule that selectively and irreversibly binds HER2 (ErbB2), including wild-type and various HER2 mutants, inhibiting its kinase activity and HER2-mediated signaling. It does not inhibit EGFR. It is studied in HER2-expressing solid tumors, including breast cancer, non-small cell lung cancer, gastric and colorectal cancers, and brain metastases.

Summary written with AI from the sources listed at the end of this page.

At a glance

Drug type: Small molecule
Targets: HER2 (ErbB2) receptor tyrosine kinase (ERBB2)
Mechanism: Inhibitor of HER2 (ErbB2) receptor tyrosine kinase (ERBB2)
Pathways: HER2 signaling, tumor cell proliferation, tumor vascularization
Therapy area: Oncology
Developer: Iambic Therapeutics, Inc (IAM)
FDA status: Investigational, not approved in the US. Most advanced trial: Phase 1

🧪 Clinical trials

Trial	Phase	Condition	Status	Sponsor
NCT06253871	Phase 1	HER2 Mutation-Related Tumors	Recruiting	IAM

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Brain Metastases From HER2 and Breast CancerBrain Metastases From Solid TumorsCNS MetastasesHER2HER2 + Breast CancerHER2 + Gastric CancerHER2 Mutation-Related TumorsHER2-positive Bladder CancerHER2-positive Breast CancerHER2-positive Colorectal CancerHER2-positive Gastroesophageal CancerHER2-Positive Solid TumorsNSCLC (Non-small Cell Lung Cancer)

Other drugs acting on ERBB2

Margetuximab FDA approved Neratinib FDA approved Trastuzumab Deruxtecan FDA approved Trastuzumab Emtansine FDA approved Zanidatamab FDA approved ADCT-502 Phase 1 BH-30643 Phase 1/2 CGT4255 Phase 1 CUDC-101 Phase 1 ELVN-002 Phase 1 Enozertinib Phase 1/2 NVL-330 Phase 1

Sources

Updated Oct 25, 2026. Something wrong or missing? Report it on the IAM page.

Follow IAM, the company behind IAM1363

See IAM's upcoming FDA decisions, trial readouts, cash runway and dilution risk, updated every day from SEC, FDA and ClinicalTrials.gov filings.

IAM catalysts and pipeline →

Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z