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Eli Lilly Co.
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Phase 2 · small molecule · Glioma
Abemaciclib (Verzenio) is an oral small-molecule antineoplastic agent developed by Eli Lilly and currently under investigation in combination with temozolomide for the treatment of newly diagnosed high-grade glioma in children and young adults. The program, identified as I3Y-MC-JPEH, is a randomized, open-label Phase 2
Internal code I3Y-MC-JPEH
Abemaciclib (Verzenio) is an oral small-molecule antineoplastic agent developed by Eli Lilly and currently under investigation in combination with temozolomide for the treatment of newly diagnosed high-grade glioma in children and young adults. The program, identified as I3Y-MC-JPEH, is a randomized, open-label Phase 2 study comparing abemaciclib plus temozolomide versus temozolomide monotherapy in pediatric and young adult patients following radiotherapy. Abemaciclib is already approved in multiple jurisdictions including Australia (since 2020), the European Union (authorized 29 January 2026), and the United States, where it is marketed under the brand name Verzenio as an oral film-coated tablet formulation. The glioma indication represents an expansion of abemaciclib's therapeutic portfolio beyond its established oncology indications. The Phase 2 trial design reflects a strategy to establish combination efficacy and safety in a pediatric population with a high unmet medical need. Current status is active, with the program advancing through clinical development to generate evidence supporting potential label expansion or new indication approval.
High-grade glioma in children and young adults represents a devastating malignancy with limited treatment options and poor long-term survival outcomes despite multimodal therapy including surgery, radiotherapy, and chemotherapy. Temozolomide remains a standard-of-care chemotherapy backbone, but outcomes remain suboptimal, creating a significant unmet medical need for combination approaches that enhance efficacy without unacceptable toxicity in this vulnerable pediatric population. Abemaciclib's mechanism as a cyclin-dependent kinase inhibitor offers a rational combination partner with potential synergistic activity. The pediatric glioma market, while smaller than adult oncology segments, carries high clinical and commercial significance due to the severity of disease, limited alternatives, and potential for substantial clinical benefit. Successful demonstration of efficacy could support label expansion and establish abemaciclib as a foundational component of combination therapy in this indication, potentially opening pediatric and young adult glioma as a new revenue stream for Eli Lilly. The competitive landscape in pediatric high-grade glioma remains relatively sparse, with few approved combination regimens specifically validated in this population, positioning a successful program as clinically and commercially meaningful.
Drug Class: Antineoplastic and immunomodulating agent (ATC L01)
Modality: Small-molecule oral therapeutic
Route of Administration: Oral (film-coated tablets, 50 mg formulation noted)
Mechanism of Action: Not yet disclosed in available facts
Target: Not yet disclosed in available facts
Related Therapies: Abemaciclib is being combined with temozolomide, an alkylating agent standard in glioma chemotherapy. The program investigates combination strategy versus monotherapy baseline.
First Approval: Abemaciclib (Verzenio) was first listed in Australia on 1 January 2020 and received additional PBS listings through 2024. EU authorization granted 29 January 2026. US approval documented under NDA208716 and NDA208855.
Patent Status: Not yet disclosed in available facts
Also known as: glial neoplasm, glial tumor, glial tumour, neoplasm of neuroglia, neoplasm of the neuroglia, neuroglial neoplasm
Prevalence: Point prevalence: 1-5 / 10 000 (Europe) — source: Orphanet, validated.
A benign or malignant brain and spinal cord tumor that arises from glial cells (astrocytes, oligodendrocytes, ependymal cells). Tumors that arise from astrocytes are called astrocytic tumors or astrocytomas. Tumors that arise from oligodendrocytes are called oligodendroglial tumors. Tumors that arise from ependymal cells are called ependymomas.
ClinicalTrials.gov lists 517 registered studies for Glioma (AACT aggregate).
Phase breakdown: NA (265), PHASE1 (85), PHASE2 (82), PHASE1/PHASE2 (33), EARLY_PHASE1 (29), PHASE3 (13), PHASE2/PHASE3 (7), PHASE4 (3)
Common investigational therapies:
Disease data sourced from MONDO Disease Ontology (MONDO:0021042), Orphanet — glioma, NCT00001150, NCT00001336, NCT00001341, NCT00001444, NCT00001500, AACT (ClinicalTrials.gov aggregate), ClinicalTrials.gov, NCT00001148, NCT00001171, NCT00001502, NCT00001573, NCT00009035, Open Targets Platform (CC BY 4.0).
Abemaciclib approved in Australia
Verzenio first listed on Australian Register of Therapeutic Goods.
Additional abemaciclib PBS listings in Australia
Expanded reimbursement listings for Verzenio in Australia.
Abemaciclib authorized in European Union
EMA authorization for Verzenio (EMEA/H/C/004302) granted.
Phase 2 glioma trial (I3Y-MC-JPEH) ongoing
Randomized, open-label study of abemaciclib plus temozolomide versus temozolomide monotherapy in children and young adults with newly diagnosed high-grade glioma post-radiotherapy.
The competitive landscape in pediatric and young adult high-grade glioma includes several approved antineoplastic agents, though few are specifically validated in combination regimens for this population. Competitors identified in the facts include Pfizer Australia (multiple agents), Janssen-Cilag (Imbruvica), Novartis (Afinitor), Regeneron (Lynozyfic), Jazz Pharmaceuticals (Vyxeos Liposomal), Amgen (Kyprolis), and others. However, these agents represent diverse therapeutic classes and indications; direct competitive positioning in pediatric high-grade glioma specifically is not fully characterized in the available facts. Temozolomide monotherapy remains the current standard backbone, and abemaciclib's combination strategy aims to improve upon this baseline. The relatively sparse landscape of approved combination therapies specifically in pediatric glioma suggests limited direct competition, positioning a successful abemaciclib combination program as potentially differentiated. Competitive intensity may increase as other CDK inhibitors or targeted agents explore similar combination approaches, but current approval status and clinical evidence in this specific population remain limited for most listed competitors.
| Therapy | Company | Mechanism | Status |
|---|---|---|---|
| PFIZER AUSTRALIA PTY LTD | Pfizer Australia Pty Ltd | — | approved |
| IMBRUVICA | Janssen-Cilag Pty Ltd | — | approved |
| AFINITOR | Novartis Pharmaceuticals | — | approved |
| LYSODREN | S.A. | — | approved |
| INLYTA | Pfizer Australia Pty Ltd | — | approved |
| LYNOZYFIC | Regeneron UK Limited | — | approved |
| VYXEOS LIPOSOMAL (PREVIOUSLY VYXEOS) | Jazz Pharmaceuticals Ireland Limited | — | approved |
| KYPROLIS | Amgen | — | approved |
| UNITUXIN | United Therapeutics Europe Ltd | — | approved |
| PACLITAXEL ACCORD | Accord Healthcare Pty. | — | approved |
| OFEV | Boehringer Ingelheim Pty Ltd | — | approved |
| ARX-IMATINIB | Alphapharm Pty Ltd | — | approved |
| EVEROLIMUS | — | FK506-binding protein 1A inhibitor | Approved |
| CARMUSTINE | — | Glutathione reductase inhibitor | Approved |
| BEVACIZUMAB | — | Vascular endothelial growth factor A inhibitor | Approved |
| VINCRISTINE SULFATE | — | Tubulin inhibitor | Phase 3 |
| VINCRISTINE | — | Tubulin inhibitor | Phase 3 |
| TRANEXAMIC ACID | — | Plasminogen inhibitor | Phase 3 |
| TRABEDERSEN | — | Transforming growth factor beta-2 mRNA antisense inhibitor | Phase 3 |
| TOVORAFENIB | — | RAF serine/threonine protein kinase inhibitor | Phase 3 |
Additional associated therapies sourced from Open Targets Platform (CC0), linked to NovaPharmaNews drug profiles where matched.
United States: Abemaciclib approved under NDA208716 and NDA208855; ANDA220238 also listed. Sponsor includes Eli Lilly and Co. and Qilu Pharmaceutical Co., Ltd. Current glioma indication (I3Y-MC-JPEH) is in Phase 2 clinical development.
European Union: Verzenio authorized 29 January 2026 (EMEA/H/C/004302) with Marketing Authorization Holder Eli Lilly Nederland B.V. Glioma indication not yet approved; Phase 2 trial ongoing.
Australia: Abemaciclib approved and listed on ARTG with multiple PBS codes (11868P, 11871T, 11876C, 14105J, 14116Y, 14134X). First listed 1 January 2020; additional listings through 2024. Sponsor: Eli Lilly Australia Pty Ltd. Glioma indication regulatory status not yet disclosed.
China (NMPA): Abemaciclib in clinical trials; NCT03988114 and NCT02152631 referenced as ongoing or completed trials in China.
Japan (PMDA): Regulatory status not yet disclosed in available facts.
Abemaciclib is an oral antineoplastic agent approved for multiple oncology indications in the US, EU, and Australia. It is currently under investigation in combination with temozolomide for newly diagnosed high-grade glioma in children and young adults.
Abemaciclib is not yet approved for glioma. The Phase 2 trial I3Y-MC-JPEH is currently active, evaluating abemaciclib plus temozolomide versus temozolomide monotherapy in this indication.
The specific mechanism of action for abemaciclib is not yet disclosed in available facts, though it is classified as an antineoplastic and immunomodulating agent.
Abemaciclib (Verzenio) is manufactured and developed by Eli Lilly and Co., with regional subsidiaries including Eli Lilly Australia Pty Ltd and Eli Lilly Nederland B.V.
Trial I3Y-MC-JPEH is a randomized, open-label Phase 2 study comparing abemaciclib plus temozolomide to temozolomide monotherapy in children and young adults with newly diagnosed high-grade glioma following radiotherapy.
The trial enrolls children and young adults with newly diagnosed high-grade glioma who have completed radiotherapy.
Abemaciclib was first listed in Australia on 1 January 2020. It received US approval under NDA208716 and NDA208855, and EU authorization on 29 January 2026.
Abemaciclib is administered orally as film-coated tablets, with a 50 mg formulation noted in the glioma trial.
Yes, abemaciclib (Verzenio) received EMA authorization on 29 January 2026 under EMEA/H/C/004302, with Eli Lilly Nederland B.V. as the Marketing Authorization Holder.
Yes, abemaciclib is approved in Australia and listed on the ARTG with multiple PBS codes since 1 January 2020, with additional listings through 2024.
The trial identifier is I3Y-MC-JPEH (internal code) with NCT ID 2022-502269-13-00.
The primary endpoint is not yet disclosed in available facts.
Results have not yet been reported. The trial is currently active.
High-grade glioma in children and young adults has poor long-term survival outcomes despite multimodal therapy, creating significant need for improved combination treatments with enhanced efficacy and acceptable safety.
The trial investigates abemaciclib in combination with temozolomide, an alkylating chemotherapy agent, compared to temozolomide monotherapy.
Abemaciclib is classified as an antineoplastic and immunomodulating agent (ATC L01), specifically a small-molecule oral therapeutic.
No partner is listed for the glioma program. Eli Lilly is the sole sponsor of trial I3Y-MC-JPEH.
I3Y-MC-JPEH → Drug → Target → Indication → Company → Trials → Competitors
Strategic Implications: Eli Lilly's investigation of abemaciclib in pediatric high-grade glioma represents a targeted expansion into an underserved indication with high unmet medical need. The Phase 2 design with temozolomide combination reflects a rational translational strategy leveraging CDK inhibition to enhance standard-of-care chemotherapy efficacy. Success could establish a new revenue stream in pediatric oncology and differentiate abemaciclib's portfolio beyond current approved indications.
Competitive Implications: The sparse competitive landscape in pediatric glioma combination therapy suggests limited direct competition at present. However, other CDK inhibitors and targeted agents may pursue similar strategies, and successful approval could prompt competitive responses. Abemaciclib's established safety and efficacy profile in other oncology indications may accelerate regulatory pathway and clinical adoption if Phase 2 data support efficacy.
Future Catalysts: Phase 2 trial completion and data readout represent the primary near-term catalyst. Positive efficacy and acceptable safety data could support Phase 3 initiation or accelerated regulatory pathways. Regulatory feedback from FDA, EMA, or other authorities on indication expansion strategy will inform development trajectory. Pediatric priority review voucher eligibility or other regulatory incentives may apply and could influence timeline.
Expected Milestones: Phase 2 trial data disclosure timeline not yet disclosed. Regulatory interactions and potential Phase 3 initiation dependent on Phase 2 results. Label expansion or new indication approval timelines contingent on clinical evidence generation and regulatory review.
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Intelligence compiled from public regulatory and clinical sources (FDA, EMA, ClinicalTrials.gov and company disclosures). Figures may be editorial or analyst estimates; verify against primary sources before relying on them.