pharma · Pyruvate Kinase Deficiency · Sickle Cell Disease · AGIO
Agios Netherlands B.V.
Agios Netherlands is a pharma organization headquartered in CAMBRIDGE, MA, NL. It trades on NYSE under ticker AGIO. Primary therapeutic focus areas include Pyruvate Kinase Deficiency, Sickle Cell Disease, Transfusion-dep
Phase 1 · small molecule · Lymphoma
AG-636 is a small-molecule therapeutic candidate developed by Agios Netherlands B.V. for the treatment of lymphoma. The program entered clinical development as a Phase 1 study (NCT03834584) but was terminated as of August 25, 2020, prior to advancement to later-stage trials. The sponsor did not disclose the drug's mech
Internal code AG636-C-001
AG-636 is a small-molecule therapeutic candidate developed by Agios Netherlands B.V. for the treatment of lymphoma. The program entered clinical development as a Phase 1 study (NCT03834584) but was terminated as of August 25, 2020, prior to advancement to later-stage trials. The sponsor did not disclose the drug's mechanism of action, molecular target, or rationale for termination. No partnership arrangements or licensing agreements have been disclosed. The program represents an early-stage oncology asset that did not progress beyond initial human safety and tolerability evaluation. With termination occurring in 2020, AG-636 is no longer under active development by Agios. The competitive lymphoma landscape includes multiple approved therapies such as ibrutinib (AbbVie), brentuximab vedotin (Takeda), and temsirolimus (Pfizer), as well as several candidates in Phase 3 development including zanubrutinib and D8220C00027.
Lymphoma represents a significant oncology indication with substantial unmet medical needs, particularly in relapsed/refractory disease and in patient populations with limited treatment options or poor tolerability profiles. The competitive landscape is populated with both approved kinase inhibitors, monoclonal antibody conjugates, and mTOR inhibitors, indicating active pharmaceutical development in this space. AG-636's termination suggests that Agios made a strategic decision to discontinue the program, potentially due to safety signals, efficacy concerns, or portfolio prioritization during Phase 1 evaluation. The lymphoma market remains clinically and commercially significant, with multiple Phase 3 programs advancing toward potential approval. Understanding why AG-636 was terminated provides insight into Agios's oncology strategy and the competitive barriers facing new entrants in lymphoma therapeutics. The program's discontinuation does not diminish the clinical relevance of lymphoma treatment innovation, but rather highlights the attrition rate inherent in early-stage oncology drug development.
Drug Class: Small-molecule oncology candidate
Modality: Small molecule
Indication: Lymphoma
Mechanism of Action: Not disclosed
Molecular Target: Not disclosed
Route of Administration: Not disclosed
Development Status: Terminated Phase 1
Related Therapies: AG-636 competes in a therapeutic class that includes approved agents such as ibrutinib (Bruton tyrosine kinase inhibitor), brentuximab vedotin (CD30-directed antibody-drug conjugate), temsirolimus (mTOR inhibitor), and investigational candidates in Phase 3 including zanubrutinib and D8220C00027.
Patent Status: Not disclosed
First Approval: Not applicable; program terminated during Phase 1
Also known as: lymphoma (Hodgkin and non-Hodgkin), lymphoma (Hodgkin's and non-Hodgkin's), lymphoma, malignant, lymphomatous, malignant lymphoma, MLYM
A malignant (clonal) proliferation of B- lymphocytes or T- lymphocytes which involves the lymph nodes, bone marrow and/or extranodal sites. This category includes Non-Hodgkin lymphomas and Hodgkin lymphomas.
ClinicalTrials.gov lists 16 registered studies for Lymphoma, Hodgkin (AACT aggregate).
Phase breakdown: NA (10), PHASE1 (3), PHASE2 (3)
Common investigational therapies:
Disease data sourced from MONDO Disease Ontology (MONDO:0005062), Orphanet — lymphoma, NCT00026208, NCT00578461, NCT01459224, NCT02996773, NCT03117036, AACT (ClinicalTrials.gov aggregate), ClinicalTrials.gov, Open Targets Platform (CC BY 4.0).
Phase 1 initiation
AG-636 Phase 1 trial (NCT03834584) initiated to evaluate safety, tolerability, and preliminary efficacy in lymphoma patients.
Program termination
AG-636 development program terminated; no advancement to Phase 2 or later stages.
The lymphoma therapeutic landscape includes multiple approved small-molecule and biologic agents. Ibrutinib (AbbVie), a Bruton tyrosine kinase inhibitor, is established as a standard-of-care option. Brentuximab vedotin (Takeda), an anti-CD30 antibody-drug conjugate, addresses Hodgkin lymphoma and select non-Hodgkin lymphoma subtypes. Temsirolimus (Pfizer) and etoposide represent mTOR and topoisomerase II inhibition strategies, respectively. Investigational competitors in Phase 3 include zanubrutinib (BEONE MEDICINES AUS PTY LTD), a next-generation BTK inhibitor, and D8220C00027 (AstraZeneca AB). Additional Phase 3 programs include NHL-014 (Xiyuan Hospital of China Academy of Chinese Medical Sciences) and ICM ADX-2191 injection (Aldeyra Therapeutics). AG-636's termination during Phase 1 suggests the candidate did not demonstrate sufficient differentiation or safety profile to warrant continued development relative to this competitive field.
| Therapy | Company | Mechanism | Status |
|---|---|---|---|
| Etoposide | Xiyuan Hospital of China Academy of Chinese Medical Sciences | small_molecule | approved |
| temsirolimus | Pfizer | small_molecule | approved |
| Brentuximab vedotin | Takeda | small_molecule | approved |
| crizotinib | Xiyuan Hospital of China Academy of Chinese Medical Sciences | small_molecule | approved |
| ONTAK (denileukin difitox, DAB389IL-2) | LIGAND PHARMACEUTICALS INC | small_molecule | approved |
| Ibrutinib | AbbVie Deutschland GmbH & Co. KG | small_molecule | approved |
| D8220C00027 | AstraZeneca AB | small_molecule | phase_3 |
| Zanubrutinib | BEONE MEDICINES AUS PTY LTD | small_molecule | phase_3 |
| ICM ADX-2191 injection | Aldeyra Therapeutics | small_molecule | phase_3 |
| NHL-014 | Xiyuan Hospital of China Academy of Chinese Medical Sciences | small_molecule | phase_3 |
| ZOLEDRONIC ACID | — | Farnesyl diphosphate synthase inhibitor | Approved |
| VORINOSTAT | — | Histone deacetylase 1 inhibitor | Approved |
| VINBLASTINE SULFATE | — | Tubulin inhibitor | Approved |
| VENETOCLAX | — | Apoptosis regulator Bcl-2 inhibitor | Approved |
| UMBRALISIB TOSYLATE | — | Tyrosine-protein kinase ABL inhibitor | Approved |
| TISAGENLECLEUCEL | — | B-lymphocyte antigen CD19 binding agent | Approved |
| THALIDOMIDE | — | CRL4(CRBN) E3 ubiquitin ligase inhibitor | Approved |
| TECLISTAMAB | — | Tumor necrosis factor receptor superfamily member 17 binding agent | Approved |
| TAZEMETOSTAT HYDROBROMIDE | — | Histone-lysine N-methyltransferase EZH2 inhibitor | Approved |
| TALQUETAMAB | — | T cell surface glycoprotein CD3 binding agent | Approved |
Additional associated therapies sourced from Open Targets Platform (CC0), linked to NovaPharmaNews drug profiles where matched.
FDA Status: Not disclosed; program terminated during Phase 1, prior to any regulatory submissions or approvals.
EMA Status: Not disclosed
PMDA (Japan) Status: Not disclosed
NMPA (China) Status: Not disclosed
Approval History: Not applicable; AG-636 did not advance to regulatory submission stage.
Clinical Trial Registration: NCT03834584 registered with ClinicalTrials.gov; trial status and results not yet disclosed.
AG-636 is a small-molecule oncology candidate developed by Agios Netherlands B.V. for the treatment of lymphoma. The program was terminated during Phase 1 clinical development in August 2020.
No. AG-636 was terminated during Phase 1 development and never advanced to regulatory submission or approval.
The mechanism of action and molecular target of AG-636 have not been disclosed by Agios Netherlands B.V.
AG-636 is developed by Agios Netherlands B.V. No manufacturing partner or licensee has been disclosed.
AG-636 was evaluated in Phase 1 trial NCT03834584. Trial results have not been reported, and the program was terminated on August 25, 2020.
Agios has not disclosed the specific reason for AG-636's termination. The decision occurred during Phase 1 evaluation, suggesting safety, efficacy, or strategic portfolio considerations.
AG-636 development is terminated as of August 25, 2020, and the program is no longer under active development.
AG-636 was being developed for the treatment of lymphoma, a hematologic malignancy.
AG-636 is a small-molecule therapeutic candidate.
No partnership or licensing arrangements have been disclosed for AG-636.
Approved lymphoma therapies include ibrutinib (AbbVie), brentuximab vedotin (Takeda), and temsirolimus (Pfizer). Phase 3 competitors include zanubrutinib and D8220C00027 (AstraZeneca).
The first disclosure date for AG-636 has not been disclosed; the latest milestone was termination on August 25, 2020.
The internal development code for AG-636 is AG636-C-001.
No published clinical trial results or data have been disclosed for AG-636 as of the latest available information.
No. The AG-636 development program was terminated in August 2020, and no active enrollment is occurring.
AG-636 was evaluated in Phase 1 trial NCT03834584; specific design details such as patient population, endpoints, and dosing have not been disclosed.
AG-636 → Drug → Target → Indication → Company → Trials → Competitors
Strategic Implications: AG-636's termination in August 2020 reflects Agios's portfolio prioritization and risk management in oncology. The sponsor elected to discontinue the program during Phase 1, suggesting insufficient clinical or preclinical data to justify advancement. This decision may indicate safety concerns, lack of efficacy signals, or strategic reallocation of resources toward higher-priority programs.
Competitive Implications: The lymphoma market remains highly competitive with established approved therapies and multiple Phase 3 candidates. AG-636's failure to progress underscores the high bar for novel oncology candidates to differentiate from existing standards of care and investigational alternatives.
Future Catalysts: No future milestones are anticipated for AG-636 given program termination. Publication of Phase 1 safety and tolerability data, if conducted, could provide retrospective insights into the termination rationale.
Expected Developments: None; program is terminated and not expected to re-enter development.
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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.