NCT07490288
- Objective
- Not yet disclosed
- Design
- Not yet disclosed
- Participants
- Not yet disclosed
- Primary endpoint
- Not yet disclosed
- Results
- Results not yet reported
pharma · Nasopharyngeal Carcinoma · Hepatocellular Carcinoma
Chinese Academy of
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Chinese Academy of is a pharma organization headquartered in TAIZHOU, CN. Primary therapeutic focus areas include Nasopharyngeal Carcinoma, Hepatocellular Carcinoma, COVID-19, Breast Cancer, Coronary Artery Disease. Nova
China, TAIZHOU, CN HQ
170 Employees
NMPA registrant Type
Company details
- Status
- Public
- HQ
- China, TAIZHOU, CN
- Employees
- 170
- Programs
- 1328
- Drugs
- 711
- Patents
- 335
Venetoclax
Phase 3 · small molecule · AML
Venetoclax (VENCLEXTA) is an oral small-molecule antineoplastic agent approved globally for multiple hematologic malignancies. The drug is currently in Phase 3 development for acute myeloid leukemia (AML) under sponsorship by Xiyuan Hospital of China Academy of Chinese Medical Sciences, with an internal code IIT2026028
Internal code IIT2026028
At a glance
- Sponsor
- Xiyuan Hospital of China Academy of Chinese Medical Sciences
- Phase
- Phase 3
- Modality
- small_molecule
- Indication
- AML
- Status
- active
- Trials
- 2
Executive summary
Venetoclax (VENCLEXTA) is an oral small-molecule antineoplastic agent approved globally for multiple hematologic malignancies. The drug is currently in Phase 3 development for acute myeloid leukemia (AML) under sponsorship by Xiyuan Hospital of China Academy of Chinese Medical Sciences, with an internal code IIT2026028. The program maintains active status with a latest milestone recorded on 20 April 2026. Venetoclax is already approved in the United States, European Union, and Australia under AbbVie's original development and commercialization. The current Phase 3 trial activity in China, represented by NCT07490288 and NCT07539818, reflects ongoing clinical investigation in the AML indication within the Chinese healthcare system. Regulatory approval has been established in major markets: FDA approval via NDA208573 and ANDA214733 (including Dr. Reddy's generic pathway), EMA authorization dated 21 October 2025 under MAH AbbVie Deutschland GmbH & Co. KG, and TGA approval in Australia with multiple PBS listings since 2019. The competitive landscape includes several approved antineoplastic agents, though venetoclax's BCL-2 inhibition mechanism differentiates it within the AML treatment armamentarium. Current development focuses on expanding clinical evidence in Chinese patient populations and potentially optimizing therapeutic outcomes in AML management.
Why this program matters
Acute myeloid leukemia remains a serious hematologic malignancy with significant unmet medical needs, particularly in elderly and treatment-resistant populations. Venetoclax addresses a critical therapeutic gap by offering an oral BCL-2 inhibitor option that has demonstrated clinical benefit in AML when combined with hypomethylating agents or low-dose cytarabine. The drug's approval trajectory across major regulatory regions underscores its clinical and commercial significance. In the Chinese market specifically, the Phase 3 trials represent an important expansion of venetoclax's clinical evidence base within a large patient population where AML incidence and treatment patterns may differ from Western cohorts. The competitive positioning is notable: venetoclax operates through a distinct mechanism (BCL-2 inhibition) compared to traditional cytotoxic chemotherapy, offering potential advantages in tolerability and efficacy profiles. Market relevance is substantial given the aging global population and increasing AML diagnosis rates. The commercial significance extends beyond monotherapy, as venetoclax's combination strategies with hypomethylating agents have become standard-of-care options in multiple jurisdictions. Patient population impact is considerable, as oral administration improves accessibility and quality of life compared to intravenous alternatives. The ongoing Phase 3 development in China reflects recognition of regional treatment optimization opportunities and supports potential label expansions or market penetration strategies in this high-population-density region.
Drug intelligence
Drug Class: Antineoplastic and immunomodulating agent (ATC L01)
Modality: Small-molecule oral agent
Route of Administration: Oral
Mechanism of Action: Not yet disclosed in the provided facts; however, venetoclax is established in literature as a selective BCL-2 inhibitor.
Target: Not yet disclosed in the provided facts.
Brand Name: VENCLEXTA (primary commercial name); VENCLYXTO (European Union designation)
Related Therapies: Venetoclax is typically used in combination with hypomethylating agents (azacitidine, decitabine) or low-dose cytarabine in AML treatment paradigms.
First Approval: FDA approval established via NDA208573; EMA authorization 21 October 2025; TGA approval in Australia with first PBS listing 1 March 2019.
Patent Status: Not yet disclosed in the provided facts.
- Therapeutic class: Antineoplastic and immunomodulating agents (L01)
- Regulatory status: Approved in US, EU, and Australia; clinical trials ongoing in China
- Manufacturers: AbbVie (original developer); Dr. Reddy's (generic pathway in US)
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
- Approved2019-03-01
TGA Approval (Australia)
Venetoclax first listed on Australian Register of Therapeutic Goods with PBS code 11630D.
- Approved2020-12-01
TGA PBS Listing Expansion
Additional PBS code 11639N added to Australian regulatory listing.
- Approved2021-12-01
TGA PBS Listing Expansion
Further PBS code 11648C added to Australian regulatory listing.
- Approved2025-10-21
EMA Authorization
European Medicines Agency granted authorization for venetoclax under EMEA/H/C/004106.
- Phase 32026-04-20
Latest Milestone (China Phase 3)
Most recent program milestone recorded for Phase 3 AML trial activity in China.
Competitive landscape
The competitive landscape for AML therapeutics includes multiple approved agents with distinct mechanisms and clinical profiles. Vyxeos Liposomal (Jazz Pharmaceuticals Ireland Limited) represents a liposomal formulation combining daunorubicin and cytarabine, offering an alternative induction strategy. Imbruvica (Janssen-Cilag Pty Ltd), a Bruton tyrosine kinase inhibitor, addresses a different molecular pathway and is approved for select hematologic malignancies. Afinitor (Novartis Pharmaceuticals), an mTOR inhibitor, operates through yet another mechanism relevant to certain cancer indications. Kyprolis (Amgen), a proteasome inhibitor, targets multiple myeloma and related conditions. Inlyta (Pfizer Australia Pty Ltd) and other tyrosine kinase inhibitors represent additional competitive options in the antineoplastic space. Paclitaxel Accord (Accord Healthcare Pty) and other chemotherapy agents continue to serve as backbone therapies. Venetoclax's competitive differentiation stems from its oral BCL-2 inhibition mechanism, which addresses apoptosis resistance in leukemic cells. The drug's approval status across major markets and ongoing Phase 3 development in China position it as an established therapeutic option rather than an emerging competitor. The combination of venetoclax with hypomethylating agents has become a preferred standard-of-care approach in many jurisdictions, providing competitive advantages over traditional chemotherapy-only regimens in terms of efficacy and tolerability profiles.
| 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 |
| TRETINOIN | — | Retinoic acid receptor agonist | Approved |
| TAGRAXOFUSP | — | Interleukin-3 receptor subunit alpha binding agent | Approved |
| SARGRAMOSTIM | — | Granulocyte-macrophage colony-stimulating factor receptor agonist | Approved |
| OLUTASIDENIB | — | Isocitrate dehydrogenase [NADP] cytoplasmic inhibitor | 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 |
Additional associated therapies sourced from Open Targets Platform (CC0), linked to NovaPharmaNews drug profiles where matched.
Regulatory intelligence
United States (FDA): Venetoclax approved via NDA208573 (AbbVie) and ANDA214733 (Dr. Reddy's generic pathway). Full approval status established.
European Union (EMA): Authorization granted 21 October 2025 under EMEA/H/C/004106 with Marketing Authorization Holder AbbVie Deutschland GmbH & Co. KG. Product marketed as VENCLYXTO in EU.
Australia (TGA): Approved with multiple PBS listings: 11630D (1 March 2019), 11639N (1 December 2020), 11648C (1 December 2021), 12188L, 12199C, 12205J, 12773G, 12803W, 12999E, 14581K. Sponsor: AbbVie Pty Ltd. Full regulatory approval status.
China (NMPA): Clinical trial status. Five active NCT-registered trials identified: NCT04965493, NCT05144243, NCT06386302, NCT06449482, NCT06536010. Current Phase 3 program (IIT2026028) sponsored by Xiyuan Hospital of China Academy of Chinese Medical Sciences with NCT IDs NCT07490288 and NCT07539818. Marketing approval status in China: not yet disclosed.
- FDA: Approved (NDA208573, ANDA214733)
- EMA: Approved (21 October 2025, EMEA/H/C/004106)
- TGA: Approved with 10 PBS codes
- NMPA: Clinical trials ongoing; approval status not yet disclosed
Clinical evidence summary
NCT07539818
- Objective
- Not yet disclosed
- Design
- Not yet disclosed
- Participants
- Not yet disclosed
- Primary endpoint
- Not yet disclosed
- Results
- Results not yet reported
Key questions answered
What is venetoclax used for?
Venetoclax is an oral antineoplastic agent approved for acute myeloid leukemia (AML) and other hematologic malignancies. It is typically used in combination with hypomethylating agents or low-dose cytarabine in AML treatment regimens.
Is venetoclax approved by the FDA?
Yes, venetoclax is FDA-approved via NDA208573 (AbbVie) and ANDA214733 (Dr. Reddy's generic pathway). It is available in the United States under the brand name VENCLEXTA.
Is venetoclax approved in Europe?
Yes, the European Medicines Agency granted authorization on 21 October 2025 under EMEA/H/C/004106. The product is marketed as VENCLYXTO in the European Union with AbbVie Deutschland GmbH & Co. KG as the Marketing Authorization Holder.
Is venetoclax approved in Australia?
Yes, venetoclax is approved by the Therapeutic Goods Administration (TGA) in Australia with 10 PBS listings since 2019. AbbVie Pty Ltd is the registered sponsor.
What is the current development status of venetoclax in China?
Venetoclax is in Phase 3 clinical trials in China for AML, sponsored by Xiyuan Hospital of China Academy of Chinese Medical Sciences. Two active trials are registered: NCT07490288 and NCT07539818. Marketing approval status in China is not yet disclosed.
How does venetoclax work mechanistically?
Venetoclax is a selective BCL-2 inhibitor that promotes apoptosis in leukemic cells by targeting anti-apoptotic proteins. The specific mechanism of action is not detailed in the current facts but is well-established in clinical literature.
What is the route of administration for venetoclax?
Venetoclax is administered orally, which provides advantages in patient convenience and quality of life compared to intravenous alternatives.
Who manufactures venetoclax?
AbbVie is the original developer and primary manufacturer of venetoclax (VENCLEXTA). Dr. Reddy's manufactures a generic version in the United States under ANDA214733.
What are the main competitors to venetoclax in AML treatment?
Competitors include Vyxeos Liposomal (Jazz Pharmaceuticals), Imbruvica (Janssen-Cilag), and various traditional chemotherapy agents. Venetoclax's BCL-2 inhibition mechanism differentiates it from most competing therapies.
When was venetoclax first approved in Australia?
Venetoclax was first listed on the Australian Register of Therapeutic Goods on 1 March 2019 with PBS code 11630D.
What are the NCT trial identifiers for the current Phase 3 program?
The current Phase 3 AML program in China includes NCT07490288 and NCT07539818, both sponsored by Xiyuan Hospital of China Academy of Chinese Medical Sciences.
What is the internal code for the current venetoclax Phase 3 program?
The internal code is IIT2026028, assigned to the Phase 3 AML trial program sponsored by Xiyuan Hospital of China Academy of Chinese Medical Sciences.
Is venetoclax a small-molecule drug?
Yes, venetoclax is classified as a small-molecule antineoplastic agent administered orally.
What is the therapeutic class of venetoclax?
Venetoclax is classified under ATC code L01 (Antineoplastic and immunomodulating agents).
Are there other clinical trials of venetoclax in China beyond the current Phase 3 program?
Yes, five additional NCT-registered trials are active in China: NCT04965493, NCT05144243, NCT06386302, NCT06449482, and NCT06536010, reflecting broader clinical investigation of venetoclax in the Chinese healthcare system.
What is the latest milestone date for the current venetoclax Phase 3 program?
The latest recorded milestone is 20 April 2026, though the specific nature of this milestone is not yet disclosed.
Entity relationship graph
Venetoclax → Drug → Target → Indication → Company → Trials → Competitors
Drugs
Molecular targets
Indication
Trials
Analyst insights
Strategic Implications: The Phase 3 development in China under Xiyuan Hospital sponsorship indicates a localized clinical investigation strategy, potentially aimed at generating Chinese regulatory evidence or optimizing dosing/combination strategies for the Chinese patient population. This approach is consistent with NMPA expectations for novel or established drugs seeking market authorization or label expansion in China.
Competitive Implications: Venetoclax's established approval status in major Western markets provides a competitive advantage over emerging AML therapeutics. The ongoing Phase 3 trials in China do not represent first-line development but rather expansion of clinical evidence in a new geographic region. This positions venetoclax defensively against newer BCL-2 inhibitors or alternative mechanism agents that may be in earlier development stages.
Future Catalysts: Key milestones include completion of Phase 3 trials NCT07490288 and NCT07539818, potential NMPA submission, and regulatory decision timelines in China. Additional label expansion opportunities may emerge from these trials, such as specific AML subtypes or combination regimens optimized for Chinese populations. Patent expiration timelines and generic competition trajectories (already underway in the US via Dr. Reddy's) will influence long-term market dynamics.
- Phase 3 completion expected to generate Chinese regulatory evidence for potential NMPA approval or label expansion
- Established global approval status provides competitive moat against emerging alternatives
- Combination therapy optimization in Chinese cohorts may support differentiated positioning
- Generic competition already active in US market; patent protection status critical for revenue sustainability
Quick answers
Concise, citable answers optimized for AI answer engines.
- What is venetoclax?
- Oral small-molecule BCL-2 inhibitor antineoplastic agent approved for AML and other hematologic malignancies.
- Brand name?
- VENCLEXTA (US/Australia); VENCLYXTO (EU).
- FDA approved?
- Yes, via NDA208573 (AbbVie) and ANDA214733 (Dr. Reddy's generic).
- EMA approved?
- Yes, authorized 21 October 2025 under EMEA/H/C/004106.
- TGA approved?
- Yes, approved in Australia with 10 PBS listings since 2019.
- Current development phase?
- Phase 3 in China for AML; already approved in US, EU, Australia.
- Indication?
- Acute myeloid leukemia (AML); approved for other hematologic malignancies.
- Route of administration?
- Oral.
- Modality?
- Small-molecule.
- Mechanism of action?
- BCL-2 inhibitor promoting apoptosis in leukemic cells.
- Sponsor of current Phase 3?
- Xiyuan Hospital of China Academy of Chinese Medical Sciences.
- Internal code?
- IIT2026028.
- NCT trial IDs?
- NCT07490288 and NCT07539818 for current Phase 3 program.
- Manufacturer?
- AbbVie (original); Dr. Reddy's (generic US).
- Therapeutic class?
- Antineoplastic and immunomodulating agents (ATC L01).
- Latest milestone date?
- 20 April 2026.
- China approval status?
- Clinical trials ongoing; marketing approval not yet disclosed.
- Key competitors?
- Vyxeos Liposomal, Imbruvica, traditional chemotherapy agents.
- First Australia approval date?
- 1 March 2019.
- Patent status?
- Not yet disclosed; generic competition active in US.
- Combination therapy?
- Typically combined with hypomethylating agents or low-dose cytarabine.
- Peak sales projection?
- Not yet disclosed.
- Partner company?
- No partner disclosed for current Phase 3 program.
- License type?
- Not yet disclosed.
- Lead investigator?
- Not yet disclosed.
- First disclosure date?
- Not yet disclosed.
Evidence & sources
- ClinicalTrials.gov NCT07490288 (clinicaltrials)
- ClinicalTrials.gov NCT07539818 (clinicaltrials)
- venetoclax AU status (fda)
- venetoclax CN status (fda)
- venetoclax EU status (ema)
- venetoclax 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.