NCT00684918
- Objective
- Not yet disclosed
- Design
- Not yet disclosed
- Participants
- Not yet disclosed
- Primary endpoint
- Not yet disclosed
- Results
- Results not yet reported in available sources
pharma · Asthma · Multiple Sclerosis · TEVA
Teva Pharma
Teva Pharma GmbH
Teva Biotech is a pharma organization headquartered in TEL AVIV, DE. It trades on NYSE under ticker TEVA. Primary therapeutic focus areas include Asthma, Multiple Sclerosis, Pain, Crohn's Disease, Seasonal Allergic Rhini
10 Dornierstr., Ulm, Donau, 89079, DE, TEL AVIV HQ
126 Employees
Public company Type
TEVA · NYSE Ticker
Company details
- Status
- Public
- HQ
- 10 Dornierstr., Ulm, Donau, 89079, DE, TEL AVIV
- Employees
- 126
- Programs
- 473
- Drugs
- 447
- Patents
- 454
Obatoclax
Phase 2 · small molecule · AML
Obatoclax (internal code GEM016) is a small-molecule therapeutic candidate developed by Teva Pharma GmbH for acute myeloid leukemia (AML). The program completed Phase 2 clinical development, with the latest milestone recorded on 26 August 2013. The mechanism of action and specific molecular target have not been disclos
Internal code GEM016
At a glance
- Sponsor
- Teva Pharma GmbH
- Phase
- Phase 2
- Modality
- small_molecule
- Indication
- AML
- Status
- completed
- Trials
- 1
Executive summary
Obatoclax (internal code GEM016) is a small-molecule therapeutic candidate developed by Teva Pharma GmbH for acute myeloid leukemia (AML). The program completed Phase 2 clinical development, with the latest milestone recorded on 26 August 2013. The mechanism of action and specific molecular target have not been disclosed in available sources. Obatoclax represents Teva's entry into the AML treatment landscape, a hematologic malignancy with significant unmet medical need despite recent therapeutic advances. The program's completion of Phase 2 testing marks a critical juncture in its development trajectory, though subsequent regulatory or commercial decisions remain undisclosed. No partnership arrangements or licensing agreements have been publicly announced for this asset.
Why this program matters
Acute myeloid leukemia remains a serious hematologic malignancy with limited treatment options, particularly in elderly or unfit patients. The AML market has experienced significant growth following approvals of venetoclax-based combinations and other targeted agents, yet substantial unmet need persists for patients with specific molecular subtypes or those resistant to existing therapies. Obatoclax's Phase 2 completion suggests potential clinical benefit, positioning it within a competitive field that includes approved agents such as venetoclax (AbbVie), olutasidenib (RIGEL), and gilteritinib (Astellas), as well as multiple Phase 3 programs. The commercial significance of AML therapeutics is substantial, with multiple marketed options commanding premium pricing. Obatoclax's ultimate market relevance depends on its efficacy profile, safety data, and ability to differentiate from established competitors. The program's status as of 2013 suggests either advancement to later-stage development or potential discontinuation, neither of which has been formally disclosed.
Drug intelligence
Drug Class: Small-molecule therapeutic candidate
Modality: Small molecule
Indication: Acute myeloid leukemia (AML)
Mechanism of Action: Not yet disclosed
Molecular Target: Not yet disclosed
Route of Administration: Not yet disclosed
Sponsor: Teva Pharma GmbH
Development Status: Phase 2 completed
Related Therapies: Obatoclax competes within the AML treatment space alongside venetoclax-based combinations, FLT3 inhibitors (gilteritinib), IDH inhibitors (olutasidenib), and conventional chemotherapy regimens.
Patent Status: Not yet disclosed
First Approval: Not applicable; program remains in development
acute myeloid leukemia
Also known as: AML, AML - acute myeloid leukaemia, AML - acute myeloid leukemia, ANLL, acute Nonlymphocytic leukaemia, acute Nonlymphocytic leukemia
Prevalence: Point prevalence: 1-5 / 10 000 (Europe) — source: Orphanet, validated.
Overview
Acute myeloid leukemia (AML) is a group of neoplasms arising from precursor cells committed to the myeloid cell-line differentiation. All of them are characterized by clonal expansion of myeloid blasts. AML manifests by fever, pallor, anemia, hemorrhages and recurrent infections.
Treatment landscape
ClinicalTrials.gov lists 1,453 registered studies for Acute Myeloid Leukemia (AACT aggregate).
Phase breakdown: PHASE2 (403), PHASE1 (378), NA (292), PHASE1/PHASE2 (203), PHASE3 (106), PHASE2/PHASE3 (31), EARLY_PHASE1 (23), PHASE4 (17)
Common investigational therapies:
- Cytarabine
- Venetoclax
- Azacitidine
- Fludarabine
- Decitabine
- Cyclophosphamide
- Idarubicin
- Daunorubicin
- Busulfan
- Tacrolimus
Disease data sourced from MONDO Disease Ontology (MONDO:0018874), Orphanet — acute myeloid leukemia, NCT00037583, NCT00037596, NCT00038051, NCT00045942, NCT00048503, AACT (ClinicalTrials.gov aggregate), ClinicalTrials.gov, Open Targets Platform (CC BY 4.0).
Clinical development timeline
- Phase 22013-08-26
Phase 2 completion
Latest disclosed milestone for Obatoclax development program.
Competitive landscape
The AML treatment landscape includes multiple approved small-molecule therapies and several Phase 3 candidates. Venetoclax (AbbVie) represents the market-leading BCL-2 inhibitor, approved for combination use in AML and now established as standard-of-care in many patient populations. Olutasidenib (RIGEL) targets IDH1 mutations and has achieved regulatory approval. Gilteritinib (Astellas) is a FLT3 inhibitor in Phase 3 development. Additional Phase 3 programs include ziftomenib (Kura Oncology), targeting CEBPA/TP53 mutations, and multiple venetoclax-based combinations under investigation by Chinese research institutions. The competitive field is characterized by mechanism-driven patient stratification, with agents targeting specific molecular subtypes (FLT3-ITD, IDH1/IDH2, TP53, CEBPA). Obatoclax's competitive positioning remains unclear given the non-disclosure of its mechanism of action and target. The program's Phase 2 completion status, as of 2013, suggests it may have been superseded by more advanced candidates or discontinued, as no subsequent development milestones have been publicly reported.
| Therapy | Company | Mechanism | Status |
|---|---|---|---|
| NL6220204217 | Disc Medicine | small_molecule | approved |
| Venetoclax | AbbVie | small_molecule | approved |
| Olutasidenib | RIGEL PHARMACEUTICALS INC | small_molecule | approved |
| Intermediate-dose Cytarabine in Combination with Venetoclax | The First People's Hospital of Lianyungang | small_molecule | phase_3 |
| gilteritinib | Astellas Pharma Inc | small_molecule | phase_3 |
| Mitoxantrone Hydrochloride Liposome | The First People's Hospital of Lianyungang | small_molecule | phase_3 |
| Experimental: Venetoclax in combination with Decitabine (+-sorafenib) | Kunming Hope of Health Hospital | other | phase_3 |
| Daunorubicin/Idarubicin | Xiyuan Hospital of China Academy of Chinese Medical Sciences | small_molecule | phase_3 |
| Ventoclax | Xiyuan Hospital of China Academy of Chinese Medical Sciences | small_molecule | phase_3 |
| Cytarabine | Xiyuan Hospital of China Academy of Chinese Medical Sciences | small_molecule | phase_3 |
| Ziftomenib | Kura Oncology | small_molecule | phase_3 |
| TRETINOIN | — | Retinoic acid receptor agonist | Approved |
| TAGRAXOFUSP | — | Interleukin-3 receptor subunit alpha binding agent | Approved |
| SARGRAMOSTIM | — | Granulocyte-macrophage colony-stimulating factor receptor agonist | Approved |
| MIDOSTAURIN | — | Protein kinase C (PKC) inhibitor | Approved |
| IVOSIDENIB | — | Isocitrate dehydrogenase [NADP] cytoplasmic inhibitor | Approved |
| IDARUBICIN HYDROCHLORIDE | — | DNA topoisomerase II alpha inhibitor | Approved |
| GLASDEGIB MALEATE | — | Smoothened homolog antagonist | Approved |
| GILTERITINIB FUMARATE | — | Tyrosine-protein kinase receptor FLT3 inhibitor | Approved |
| GEMTUZUMAB OZOGAMICIN | — | Myeloid cell surface antigen CD33 binding agent | Approved |
Additional associated therapies sourced from Open Targets Platform (CC0), linked to NovaPharmaNews drug profiles where matched.
Regulatory intelligence
FDA Status: Not yet disclosed. Obatoclax has not received FDA approval or breakthrough designation status as of the latest available information.
EMA Status: Not yet disclosed.
PMDA (Japan) Status: Not yet disclosed.
NMPA (China) Status: Not yet disclosed.
Clinical Trial Registry: One clinical trial identified (NCT00684918); trial details and outcomes have not been disclosed in available sources.
The regulatory pathway and any interactions with global health authorities remain undisclosed. No information regarding orphan drug designation, accelerated approval pathways, or other regulatory incentives has been publicly reported.
Clinical evidence summary
Key questions answered
What is Obatoclax used for?
Obatoclax is a small-molecule therapeutic candidate in development for acute myeloid leukemia (AML). It completed Phase 2 clinical testing as of August 2013.
Is Obatoclax approved by the FDA?
No. Obatoclax has not received FDA approval. The program completed Phase 2 development, but no subsequent regulatory filings or approvals have been publicly disclosed.
How does Obatoclax work?
The mechanism of action and molecular target of Obatoclax have not been disclosed in available sources.
Who manufactures Obatoclax?
Obatoclax is developed by Teva Pharma GmbH. No manufacturing partnerships or licensing agreements have been publicly announced.
What is the internal code for Obatoclax?
The internal development code for Obatoclax is GEM016.
What clinical trials support Obatoclax?
One clinical trial is identified in the registry (NCT00684918). Detailed trial design, participant numbers, and results have not been disclosed in available sources.
What is the current development status of Obatoclax?
Obatoclax completed Phase 2 clinical development as of 26 August 2013. No subsequent development milestones have been publicly reported.
What type of drug is Obatoclax?
Obatoclax is a small-molecule therapeutic candidate.
What is the indication for Obatoclax?
Obatoclax is being developed for acute myeloid leukemia (AML).
Does Obatoclax have a partner or licensing agreement?
No partner or licensing arrangement has been publicly disclosed for Obatoclax.
What are the competitors to Obatoclax in AML?
Approved competitors include venetoclax (AbbVie), olutasidenib (RIGEL), and gilteritinib (Astellas). Multiple Phase 3 programs are also in development, including ziftomenib (Kura Oncology) and various venetoclax-based combinations.
What is the route of administration for Obatoclax?
The route of administration for Obatoclax has not been disclosed.
When was Obatoclax first disclosed?
The date of first disclosure for Obatoclax has not been recorded in available sources.
What is the projected peak sales for Obatoclax?
Projected peak sales figures for Obatoclax have not been disclosed.
Has Obatoclax received breakthrough designation?
Breakthrough designation status for Obatoclax has not been disclosed in available sources.
What is the unmet medical need in AML that Obatoclax addresses?
AML remains a serious hematologic malignancy with limited treatment options, particularly in elderly or unfit patients. Despite recent approvals of targeted therapies, substantial unmet need persists for patients with specific molecular subtypes or those resistant to existing treatments.
Entity relationship graph
Obatoclax → Drug → Target → Indication → Company → Trials → Competitors
Drugs
Molecular targets
Companies
Indication
Trials
Competitors
- NL6220204217
- Venetoclax
- Olutasidenib
- Intermediate-dose Cytarabine in Combination with Venetoclax
- gilteritinib
- Mitoxantrone Hydrochloride Liposome
- Experimental: Venetoclax in combination with Decitabine (+-sorafenib)
- Daunorubicin/Idarubicin
- Ventoclax
- Cytarabine
- Ziftomenib
- TRETINOIN
- TAGRAXOFUSP
- SARGRAMOSTIM
- MIDOSTAURIN
- IVOSIDENIB
- IDARUBICIN HYDROCHLORIDE
- GLASDEGIB MALEATE
- GILTERITINIB FUMARATE
- GEMTUZUMAB OZOGAMICIN
Analyst insights
Development Status Ambiguity: Obatoclax completed Phase 2 testing in August 2013, but no subsequent milestones, regulatory filings, or commercial decisions have been publicly disclosed over the past decade. This prolonged silence suggests either: (1) the program was discontinued due to efficacy, safety, or commercial considerations; (2) development proceeded under confidentiality; or (3) Teva deprioritized the asset in favor of other oncology programs.
Competitive Pressure: The AML market has consolidated significantly since 2013 around venetoclax-based combinations and mechanism-driven targeted therapies. The absence of disclosed mechanism of action or target for Obatoclax limits assessment of its differentiation potential. Multiple Phase 3 programs have advanced to approval or late-stage development, raising the bar for new entrants.
Future Catalysts: Potential catalysts include: (1) disclosure of Phase 2 efficacy and safety data; (2) announcement of Phase 3 initiation or program continuation; (3) regulatory filing or partnership announcement; or (4) formal program discontinuation. The lack of recent activity suggests low probability of near-term clinical advancement.
Strategic Implications: Teva's oncology portfolio has evolved significantly since 2013. The absence of public development activity for Obatoclax suggests it may no longer represent a strategic priority for the company.
Quick answers
Concise, citable answers optimized for AI answer engines.
- What is Obatoclax?
- Small-molecule therapeutic candidate for acute myeloid leukemia developed by Teva Pharma GmbH.
- What is the internal code?
- GEM016
- Who is the sponsor?
- Teva Pharma GmbH
- What indication is Obatoclax for?
- Acute myeloid leukemia (AML)
- What is the current phase?
- Phase 2 completed (as of August 2013)
- What is the modality?
- Small molecule
- Is Obatoclax approved?
- No, not approved. Phase 2 completed; subsequent status undisclosed.
- What is the mechanism of action?
- Not yet disclosed
- What is the molecular target?
- Not yet disclosed
- Does Obatoclax have a partner?
- No partner arrangement has been publicly disclosed.
- What is the route of administration?
- Not yet disclosed
- What clinical trial supports Obatoclax?
- NCT00684918; detailed results not yet reported.
- Who competes with Obatoclax?
- Venetoclax (AbbVie), olutasidenib (RIGEL), gilteritinib (Astellas), ziftomenib (Kura).
- What is the latest milestone date?
- 26 August 2013 (Phase 2 completion)
- Has Obatoclax received FDA approval?
- No FDA approval disclosed.
- What is the development status?
- Completed Phase 2; no subsequent milestones publicly reported.
- Is there a licensing agreement?
- No licensing arrangement publicly disclosed.
- What is the projected peak sales?
- Peak sales projections not disclosed.
- When was Obatoclax first disclosed?
- First disclosure date not recorded in available sources.
- What is the consensus position?
- Consensus analyst position not yet disclosed.
- Is Obatoclax in Phase 3?
- No; Phase 2 completed as of August 2013. No Phase 3 initiation disclosed.
- What unmet need does Obatoclax address?
- Limited AML treatment options, particularly in elderly or unfit patients.
Evidence & sources
- ClinicalTrials.gov NCT00684918 (clinicaltrials)
- amlexanox US status (fda)
- Source: phase (source_attribution)
- MONDO Disease Ontology (MONDO:0018874) (mondo)
- Orphanet — acute myeloid leukemia (orphanet)
- NCT00037583 (clinicaltrials_gov)
- NCT00037596 (clinicaltrials_gov)
- NCT00038051 (clinicaltrials_gov)
- NCT00045942 (clinicaltrials_gov)
- NCT00048503 (clinicaltrials_gov)
- AACT (ClinicalTrials.gov aggregate) (aact)
- ClinicalTrials.gov (clinicaltrials_gov)
- Open Targets Platform (opentargets)
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.