KRT-232

Kartos Therapeutics, Inc. · Phase 2 active Small molecule

KRT-232 is a CDK4/6 inhibitor Small molecule drug developed by Kartos Therapeutics, Inc.. It is currently in Phase 2 development for Myeloproliferative neoplasms. Also known as: navtemadlin.

Inhibits CDK4/6

Inhibits CDK4/6 Used for Myeloproliferative neoplasms.

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 name	KRT-232
Also known as	navtemadlin
Sponsor	Kartos Therapeutics, Inc.
Drug class	CDK4/6 inhibitor
Target	CDK4/6
Modality	Small molecule
Therapeutic area	Oncology
Phase	Phase 2

Mechanism of action

KRT-232 is a potent and selective inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6), which play a critical role in the progression of the cell cycle.

Approved indications

• Myeloproliferative neoplasms

Common side effects

• Fatigue
• Nausea
• Diarrhea

Key clinical trials

• Testing the Addition of an Anti-cancer Drug, Navtemadlin, to the Usual Treatments (Cytarabine and Idarubicin) in Patients With Acute Myeloid Leukemia (PHASE1)
• Testing a New Chemotherapy Drug, KRT-232 (AMG-232) in Combination With Decitabine and Venetoclax in Patients With Acute Myeloid Leukemia (PHASE1)
• Testing the Addition of KRT-232 (AMG 232) to Usual Chemotherapy for Relapsed Multiple Myeloma (PHASE1)
• Testing the Ability of AMG 232 (KRT 232) to Get Into the Tumor in Patients With Brain Cancer (PHASE1)
• Study of Navtemadlin add-on to Ruxolitinib in JAK Inhibitor-Naïve Patients With Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib (PHASE3)
• Navtemadlin and Radiation Therapy in Treating Patients With Soft Tissue Sarcoma (PHASE1)
• Study of Navtemadlin as Maintenance Therapy in TP53WT Advanced or Recurrent Endometrial Cancer (PHASE2, PHASE3)
• Study of Navtemadlin Plus Pembrolizumab as Maintenance Therapy in Locally Advanced and Metastatic Non-Small Cell Lung Cancer (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:

• KRT-232 CI brief — competitive landscape report
• KRT-232 updates RSS · CI watch RSS
• Kartos Therapeutics, Inc. portfolio CI

Frequently asked questions about KRT-232

What is KRT-232?

KRT-232 is a CDK4/6 inhibitor drug developed by Kartos Therapeutics, Inc., indicated for Myeloproliferative neoplasms.

How does KRT-232 work?

Inhibits CDK4/6

What is KRT-232 used for?

KRT-232 is indicated for Myeloproliferative neoplasms.

Who makes KRT-232?

KRT-232 is developed by Kartos Therapeutics, Inc. (see full Kartos Therapeutics, Inc. pipeline at /company/kartos-therapeutics-inc).

Is KRT-232 also known as anything else?

KRT-232 is also known as navtemadlin.

What drug class is KRT-232 in?

KRT-232 belongs to the CDK4/6 inhibitor class. See all CDK4/6 inhibitor drugs at /class/cdk4-6-inhibitor.

What development phase is KRT-232 in?

KRT-232 is in Phase 2.

What are the side effects of KRT-232?

Common side effects of KRT-232 include Fatigue, Nausea, Diarrhea.

What does KRT-232 target?

KRT-232 targets CDK4/6 and is a CDK4/6 inhibitor.

Related

• Drug class: All CDK4/6 inhibitor drugs
• Target: All drugs targeting CDK4/6
• Manufacturer: Kartos Therapeutics, Inc. — full pipeline
• Therapeutic area: All drugs in Oncology
• Indication: Drugs for Myeloproliferative neoplasms
• Also known as: navtemadlin