OncoSignal
Live from Open Targets Platform, fetched 2026-11-11 15:28 UTC. Every row links to its source record.

CDK6 cyclin dependent kinase 6

ENSG00000105810 · protein coding · Open Targets profile

Serine/threonine-protein kinase involved in the control of the cell cycle and differentiation; promotes G1/S transition. Phosphorylates pRB/RB1 and NPM1. Interacts with D-type G1 cyclins during interphase at G1 to form a pRB/RB1 kinase and controls the entrance into the cell cycle. Involved in initiation and maintenance of cell cycle exit during cell differentiation; prevents cell proliferation and negatively regulates cell differentiation, but is required for the proliferation of specific cell types (e.g. erythroid and hematopoietic cells). Essential for cell proliferation within the dentate gyrus of the hippocampus and the subventricular zone of the lateral ventricles. Required during thymocyte development. Promotes the production of newborn neurons, probably by modulating G1 length. Promotes, at least in astrocytes, changes in patterns of gene expression, changes in the actin cytoskeleton including loss of stress fibers, and enhanced motility during cell differentiation. Prevents myeloid differentiation by interfering with RUNX1 and reducing its transcription transactivation activity, but promotes proliferation of normal myeloid progenitors. Delays senescence. Promotes the proliferation of beta-cells in pancreatic islets of Langerhans. May play a role in the centrosome organization during the cell cycle phases (PubMed:23918663). {ECO:0000269|PubMed:12833137, ECO:0000269|PubMed:14985467, ECO:0000269|PubMed:15254224, ECO:0000269|PubMed:15809340, ECO:0000269|PubMed:17420273, ECO:0000269|PubMed:17431401, ECO:0000269|PubMed:20333249, ECO:0000269|PubMed:20668294, ECO:0000269|PubMed:23918663, ECO:0000269|PubMed:8114739}.

6 of the 12 drugs recorded against CDK6 are approved, and 1 more reached Phase 3

Each band is a group of drugs. It runs from the kind of drug on the left to the furthest stage that drug has reached in any disease on the right. Thicker bands mean more drugs.

6 small molecule drugs at Approved: TRILACICLIB DIHYDROCHLORIDE, RIBOCICLIB SUCCINATE, RIBOCICLIB, ABEMACICLIB, TRILACICLIB, PALBOCICLIB1 small molecule drug at Phase 3: ALVOCIDIB3 small molecule drugs at Phase 2: RONICICLIB, UCN-01, AT-75192 small molecule drugs at Phase 1: AZD-5438, PHA-793887Small molecule 12Approved 6Phase 3 1Phase 2 3Phase 1 2

Approved bands are highlighted. Withdrawn means the drug was pulled from the market or from development. A combined phase counts as the later one (Phase 1/2 is shown as Phase 2). Hover a band for the drug names. Source: Open Targets Platform, fetched live.

In 12 of 15 cancers, the evidence for CDK6 comes mainly from mutations found in tumours

Each row is a cancer, strongest overall evidence first. The two dots show how strong the inherited (germline) and tumour-mutation (somatic) evidence is; the line between them is the gap.

Inherited (germline) variantsMutations in tumours (somatic)
00.250.50.751breast cancerbreast cancersmall cell lung carcinomasmall cell lung carcinomasmall cell lung carcinoma: somatic 0.46breast carcinomabreast carcinomabreast carcinoma: somatic 0.46breast neoplasmbreast neoplasmprostate adenocarcinomaprostate adenocarcinomaprostate adenocarcinoma: somatic 0.61HER2 positive breast carcinomaHER2 positive breast carcinomaHER2 positive breast carcinoma: somatic 0.61esophageal adenocarcinomaesophageal adenocarcinomaesophageal adenocarcinoma: somatic 0.61pancreatic ductal adenocarcinomapancreatic ductal adenocarcinomapancreatic ductal adenocarcinoma: somatic 0.61pancreatic neuroendocrine tumorpancreatic neuroendocrine tumorpancreatic neuroendocrine tumor: somatic 0.61non-small cell lung carcinomanon-small cell lung carcinomanon-small cell lung carcinoma: somatic 0.46head and neck squamous cell carcinomahead and neck squamous cell carcinomahead and neck squamous cell carcinoma: somatic 0.46clear cell renal carcinomaclear cell renal carcinomaclear cell renal carcinoma: somatic 0.46clear cell renal carcinoma: germline 0.49lymphoid neoplasmlymphoid neoplasmlymphoid neoplasm: somatic 0.61superficial spreading melanomasuperficial spreading melanomasuperficial spreading melanoma: somatic 0.61hemangioblastomahemangioblastomahemangioblastoma: somatic 0.61

Scores run from 0 (no evidence) to 1 (strongest). A missing dot at 0 means Open Targets holds no evidence of that kind. Source: Open Targets Platform, fetched live.

Tractability

Small molecule
Approved Drug, Structure with Ligand, High-Quality Ligand, High-Quality Pocket, Druggable Family
PROTAC
Literature, Database Ubiquitination, Half-life Data, Small Molecule Binder

gnomAD loss of function constraint: o/e 0.1618500053882599 (upper bound 0.31944000720977783). Low values mean loss of function is poorly tolerated, a safety flag for inhibition.

Who runs trials of these drugs

Principal investigators and study chairs on 400 registry trials, updated in the last three years, of the most advanced drugs against CDK6 (trilaciclib, ribociclib, abemaciclib, palbociclib, alvocidib, roniciclib, UCN-01, AT-7519), ranked by Phase 2+ trials. Live from ClinicalTrials.gov.

163 of 376 trials of drugs against CDK6 have sites only in United States

Registry trials of trilaciclib, ribociclib, abemaciclib, palbociclib, alvocidib, roniciclib, UCN-01, AT-7519 updated in the last three years, counted by the country group of their listed sites. A trial with sites in several groups counts in each; 250 of 376 have all sites in one country.

Sites only in this groupSites here and elsewhere
United StatesUnited States: 163 trials with sites only hereUnited States: 108 trials with sites here and elsewhere271ChinaChina: 32 trials with sites only hereChina: 34 trials with sites here and elsewhere66EuropeEurope: 51 trials with sites only hereEurope: 92 trials with sites here and elsewhere143JapanJapan: 4 trials with sites only hereJapan: 36 trials with sites here and elsewhere40OtherOther: 14 trials with sites only hereOther: 100 trials with sites here and elsewhere114

Site counts are not patients per country, and trials registered only outside ClinicalTrials.gov are not covered. Where sites are is a fact about the record, not a judgement of its quality. Europe is the EU and EEA, the UK and Switzerland. 24 trials list no sites and are left out. Source: ClinicalTrials.gov, fetched live.

131 trials of drugs against CDK6 were stopped early; 13 give no reason

Terminated, withdrawn and suspended interventional trials of trilaciclib, ribociclib, abemaciclib, palbociclib, alvocidib, roniciclib, UCN-01, AT-7519, AZD-5438, PHA-793887, newest update first, live from ClinicalTrials.gov. Each reason is quoted exactly as the registry gives it; we do not sort reasons into safety, efficacy or business. Dates are the last registry update. Showing the 25 most recent of 131.

  • terminated · 2026-11-02 · Mayo Clinic · Abemaciclib
    “The primary biomarker (CD8/FOXP3) was rarely observed to be < 1.6 in residual tumors examined in first stage of study.”
  • terminated · 2026-10-27 · Pfizer · Ribociclib
    “Enrollment was permanently closed for strategic business reasons after 20 participants enrolled in Ph 1b. The decision was not related to safety, efficacy, benefit-risk, or participant welfare. The planned Ph 2 and DDI components were not initiated.”
  • terminated · 2026-10-21 · Novartis Pharmaceuticals · Ribociclib
    “Business reasons and not based on any safety concerns.”
  • terminated · 2026-10-15 · Praful Ravi, MB BCHir, MRCP · Abemaciclib
    “The trial was intended to be Phase 1/2 but did not move forward to Phase 2 since the company providing drug and funding (Lilly) withdrew support for the trial based on data relating to abemaciclib in advanced prostate cancer.”
  • terminated · 2026-10-14 · UNICANCER · Ribociclib
    “poor accrual”
  • terminated · 2026-09-24 · Tvardi Therapeutics, Incorporated · Palbociclib, ribociclib
    “The study was terminated prior to Phase 2 due to slow accrual.”
  • terminated · 2026-09-04 · University of Utah · Ribociclib
    “No accrual in one year”
  • terminated · 2026-07-22 · M.D. Anderson Cancer Center · Palbociclib
    “<75% participation”
  • terminated · 2026-07-10 · Novartis Pharmaceuticals · Ribociclib
    “Novartis terminated the trial early because the collected data were sufficient to perform the analysis stated for the primary endpoint.”
  • terminated · 2026-06-26 · Eli Lilly and Company · Abemaciclib
    “The study was terminated early as related study I3Y-MC-JPCM (NCT03706365) did not meet its primary endpoint.”
  • terminated · 2026-06-25 · SOLTI Breast Cancer Research Group · Ribociclib + Letrozole OR Fulvestrant, Palbociclib + Letrozole OR Fulvestrant
    “The study was prematurely halted because enrollment was significantly delayed compared with the original projections due to the evolving therapeutic landscape.”
  • terminated · 2026-05-22 · University of Arizona · Abemaciclib
    “Standard of care therapy for Stage III-IVA HNSCC updated in June to include neoadjuvant + adjuvant immunotherapy.”
  • terminated · 2026-04-28 · OHSU Knight Cancer Institute · Abemaciclib
    “Loss of support.”
  • terminated · 2026-04-22 · Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Ribociclib
    “Sponsor-PI decision. An analysis of the primary endpoint concluded that the addition of ribociclib to standard of care enzalutamide did not demonstrate benefit, an all active subjects were removed from the study.”
  • withdrawn · 2026-04-15 · Centre Antoine Lacassagne · Ribociclib Oral Tablet
    “Sponsor decision due to recruitment default”
  • terminated · 2026-03-31 · Criterium, Inc. · Abemaciclib
    “Study was terminated due to delayed recruitment.”
  • terminated · 2026-03-10 · Yael P Mosse · Ribociclib
    “The goals of Part 1 (molecular screening) were met, but lack of therapies to match molecular aberrations made Part 2 (treatment) no longer feasible.”
  • terminated · 2026-02-20 · Dana-Farber Cancer Institute · Abemaciclib
    “Slow accrual”
  • suspended · 2026-02-13 · Dana-Farber Cancer Institute · Palbociclib
    “Funding and drug supply to continue the study are pending.”
  • withdrawn · 2026-02-12 · Danish Breast Cancer Cooperative Group · Ribociclib with ET, Abemaciclib with ET
    “Lack of funding”
  • terminated · 2025-11-28 · Blueprint Medicines Corporation · Ribociclib
    “This trial was terminated prior to the initiation of Phase 2 for reasons not due to safety concerns.”
  • terminated · 2025-11-24 · Sanofi · Palbociclib, Abemaciclib
    “Sponsor decision to prematurely stop the study, not linked to any safety concern.”
  • terminated · 2025-11-12 · NiKang Therapeutics, Inc. · palbociclib
    “This study was terminated as a result of Sponsor portfolio reprioritization.”
  • terminated · 2025-10-10 · Novartis Pharmaceuticals · Ribociclib
    “Study halted early due to high toxicity risk (from BHLRM model) in combo treatment and inability to identify recommended Phase 2 dose in initial phase (Phase 1-Part A), making continuation to subsequent phases (Phase 1-Part B and Phase 2) unfeasible.”
  • terminated · 2025-09-30 · Novartis Pharmaceuticals · Ribociclib
    “Business reasons”
Paediatric incentives and obligations for CDK6's drugs

For trilaciclib, ribociclib, abemaciclib, palbociclib, alvocidib, roniciclib, UCN-01, AT-7519, AZD-5438, PHA-793887: what EMA and FDA publish about paediatric plans, orphan status and pediatric approvals, and how many registered studies take children. Each line is a yes, no or not published fact from the record linked under it; none of it is a forecast.

  • FDA pediatric target list: yes · CDK6 is on the list. Membership alone neither requires nor waives a pediatric study.
  • EU paediatric investigation plan: yes · EMA/PE/0000241250 (trilaciclib (dihydrochloride), Prevention of chemotherapy-induced myelosuppression in small-cell lung cancer): P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), 16 May 2025; EMA/PE/0000228776 (abemaciclib, Treatment of glioma): PM: decision on the application for modification of an agreed PIP, 28 Jan 2025; EMEA-002765-PIP02-21-M01 (ribociclib, Treatment of neuroblastoma): PM: decision on the application for modification of an agreed PIP, 17 Jul 2024; EMEA-002342-PIP01-18-M04 (abemaciclib, Treatment of Ewing sarcoma): PM: decision on the application for modification of an agreed PIP, 7 Feb 2024; +6 more
    Rule: An EMA PIP decision (agreement, modification or waiver) lists the drug as its active substance, exact name. Source: EMA data download (dated snapshot), 2026-11-11
  • EU orphan designation: yes · EU/3/15/1437 positive 12 Feb 2015: Treatment of acute myeloid leukaemia; EU/3/07/485 positive 23 Oct 2007: Treatment of chronic lymphocytic leukaemia
    Rule: An EU orphan designation lists the drug as its active substance (exact name) or belongs to a medicine that does; withdrawn and expired designations are listed with their status. Source: EMA data download (dated snapshot), 2026-11-11
  • Authorised in the EU: yes · Palbociclib Viatris: authorised since 19 Jun 2026; Zinmyleo: application withdrawn; Verzenios: authorised since 26 Sept 2018; Kisqali: authorised since 22 Aug 2017; +1 more
    Rule: An EMA medicine record lists the drug as its active substance or INN, exact name; national-only authorisations are not in this file. Source: EMA data download (dated snapshot), 2026-11-11
  • FDA orphan designation: not published · FDA's orphan designation database turns away automated requests, so this app does not read it; search it by hand at the link
    Rule: Would be: an FDA orphan designation names the drug. Source: FDA orphan designations search
  • FDA pediatric oncology approval: no · FDA's table lists no pediatric approval of trilaciclib, ribociclib, abemaciclib, palbociclib, alvocidib, roniciclib, ucn-01, at-7519, azd-5438, pha-793887
    Rule: FDA's Pediatric Oncology Drug Approvals table names the drug. Source: FDA Pediatric Oncology Drug Approvals (content current as of 2026-03-03), 2026-11-11
  • Registered studies open to children: yes · 54 interventional studies of trilaciclib, ribociclib, abemaciclib, palbociclib, alvocidib, roniciclib, ucn-01, at-7519, azd-5438, pha-793887 include patients under 18; 22 are recruiting, not yet recruiting or active
    Rule: The registry's age group includes Child (birth to 17 years), which also counts studies that set no minimum age. Source: ClinicalTrials.gov search, 2026-11-11

Rare pediatric disease voucher. FDA, content current as of 29 Apr 2026: “As of February 3, 2026, enactment of the Consolidated Appropriations Act, 2026, the rare pediatric disease PRV program will sunset after September 30, 2029. FDA may not award any PRVs under this program after September 30, 2029.” Voucher sale prices are not shown here; they appear only as company-reported news. FDA: Rare Pediatric Disease Designation and Priority Review Voucher Programs

All 12 drugs and clinical candidates as a table

Each drug, stage and indication links to its Open Targets record, where the trials and approvals behind it are listed. Salt forms (for example a mesylate) are listed as Open Targets records them, as separate entries.

DrugTypeHighest stageIndicationsSource records
TRILACICLIB DIHYDROCHLORIDESmall moleculeapprovalsmall cell lung carcinomaOpen Targets · ChEMBL
RIBOCICLIB SUCCINATESmall moleculeapprovalbreast cancer, neoplasm, breast carcinomaOpen Targets · ChEMBL
RIBOCICLIBSmall moleculephase 4breast neoplasm, breast cancer, melanoma, hematopoietic and lymphoid cell neoplasm, teratoma, neuroendocrine neoplasm, hepatocellular carcinoma, well-differentiated liposarcoma, +44 moreOpen Targets · ChEMBL
ABEMACICLIBSmall moleculephase 4breast cancer, breast neoplasm, neoplasm, breast carcinoma, non-small cell lung carcinoma, lung cancer, liposarcoma, prostate cancer, +71 moreOpen Targets · ChEMBL
TRILACICLIBSmall moleculephase 4small cell lung carcinoma, myelosuppression, triple-negative breast carcinoma, urothelial carcinoma, non-small cell lung carcinoma, breast cancer, HER2 positive breast carcinoma, exocrine pancreatic carcinoma, +4 moreOpen Targets · ChEMBL
PALBOCICLIBSmall moleculephase 4breast cancer, breast carcinoma, breast neoplasm, neoplasm, cancer, soft tissue sarcoma, head and neck squamous cell carcinoma, estrogen-receptor positive breast cancer, +88 moreOpen Targets · ChEMBL
ALVOCIDIBSmall moleculephase 3acute myeloid leukemia by FAB classification, mantle cell lymphoma, non-Hodgkin lymphoma, prostate cancer, B-cell chronic lymphocytic leukemia, melanoma, soft tissue sarcoma, esophageal cancer, +30 moreOpen Targets · ChEMBL
RONICICLIBSmall moleculephase 2small cell lung carcinoma, non-small cell lung carcinoma, cancerOpen Targets · ChEMBL
UCN-01Small moleculephase 2non-small cell lung carcinoma, renal cell carcinoma, kidney cancer, exocrine pancreatic carcinoma, melanoma, fallopian tube cancer, malignant epithelial tumor of ovary, ovarian carcinoma, +15 moreOpen Targets · ChEMBL
AT-7519Small moleculephase 2mantle cell lymphoma, B-cell chronic lymphocytic leukemia, plasma cell myelomaOpen Targets · ChEMBL
AZD-5438Small moleculephase 1–Open Targets · ChEMBL
PHA-793887Small moleculephase 1–Open Targets · ChEMBL