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APG-1252
APG-1252 is a Bcl-2/Bcl-xL inhibitor Small molecule drug developed by Ascentage Pharma Group Inc.. It is currently in Phase 1 development for Solid tumors. Also known as: APG-1252 for injection, Pelcitoclax.
APG-1252 is a Bcl-2 and Bcl-xL inhibitor that induces apoptosis in cancer cells.
APG-1252 is a small molecule being studied in clinical trials for various conditions, including Small Cell Lung Cancer and Other Solid Tumors, Myelofibrosis, Small Cell Lung Cancer, Advanced Endometrial Carcinoma, and Metastatic Endometrial Carcinoma. The safety, pharmacokinetic, and pharmacodynamic properties of APG-1252 are being evaluated in a Phase I study.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | APG-1252 |
|---|---|
| Also known as | APG-1252 for injection, Pelcitoclax |
| Sponsor | Ascentage Pharma Group Inc. |
| Drug class | Bcl-2/Bcl-xL inhibitor |
| Target | Bcl-2, Bcl-xL |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 1 |
Mechanism of action
APG-1252 selectively binds to Bcl-2 and Bcl-xL proteins, disrupting their anti-apoptotic function and leading to the activation of caspases and subsequent cell death in tumor cells.
Approved indications
- Solid tumors
Common side effects
- Neutropenia
- Thrombocytopenia
Key clinical trials
- Testing the Combination of APG-1252 (Pelcitoclax) and Cobimetinib in Recurrent Ovarian and Endometrial Cancers (PHASE1)
- A Study of APG-1252 Plus Osimertinib(AZD9291) in EGFR TKI Resistant NSCLC Patients (PHASE1)
- A Study of Pelcitoclax (APG-1252) in Patients With Neuroendocrine Tumors (PHASE1)
- APG-1252 Monotherapy or in Combination With Other Therapeutic Agent in Subjects With Relapsed or Refractory Non-Hodgkin Lymphoma (PHASE1, PHASE2)
- A Study of APG-1252 in Patients With SCLC or Other Solid Tumors (PHASE1)
- A Study of APG-1252 in Patients With Myelofibrosis Who Progressed After Initial Therapy (PHASE1, PHASE2)
- Study of APG-1252 Plus Paclitaxel in Patients With Relapsed/Refractory Small Cell Lung Cancer (PHASE1, PHASE2)
- APG-1252 in Patients With SCLC or Advanced Solid Tumors (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- APG-1252 CI brief — competitive landscape report
- APG-1252 updates RSS · CI watch RSS
- Ascentage Pharma Group Inc. portfolio CI
Frequently asked questions about APG-1252
What is APG-1252?
How does APG-1252 work?
What is APG-1252 used for?
Who makes APG-1252?
Is APG-1252 also known as anything else?
What drug class is APG-1252 in?
What development phase is APG-1252 in?
What are the side effects of APG-1252?
What does APG-1252 target?
Related
- Drug class: All Bcl-2/Bcl-xL inhibitor drugs
- Target: All drugs targeting Bcl-2, Bcl-xL
- Manufacturer: Ascentage Pharma Group Inc. — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Solid tumors
- Also known as: APG-1252 for injection, Pelcitoclax
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing