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Tolinapant
Tolinapant is a Small molecule drug developed by Taiho Oncology, Inc.. It is currently in Phase 1 development. Also known as: ASTX660, 1799328-86-1, XIAP/cIAP1 Antagonist ASTX660, ASTX 660.
Tolinapant is a small molecule used in clinical trials for various conditions, including relapsed/refractory peripheral T-cell lymphoma and anatomic stages III and IV breast cancer. It is being studied in combination with oral decitabine/cedazuridine and as a standalone treatment in these trials.
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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 | Tolinapant |
|---|---|
| Also known as | ASTX660, 1799328-86-1, XIAP/cIAP1 Antagonist ASTX660, ASTX 660 |
| Sponsor | Taiho Oncology, Inc. |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- A Study of Tolinapant in Combination With Oral Decitabine/Cedazuridine and Oral Decitabine/Cedazuridine Alone in Participants With Relapsed/Refractory Peripheral T-cell Lymphoma (R/R PTCL) (PHASE1)
- ASTEROID: A Trial of ASTX660 in Combination With Pembrolizumab (PHASE1)
- Tolinapant and Radiation for Cisplatin-Ineligible, Previously Untreated, Locally Advanced Head and Neck Cancer (EARLY_PHASE1)
- Testing the Addition of an Investigational Anti-Cancer Drug, ASTX660 (Tolinapant), to a Usual Chemotherapy Treatment (Eribulin) for Treatment of Advanced Triple Negative Breast Cancer (PHASE1)
- Testing the Addition of ASTX660 (Tolinapant) to the Usual Chemotherapy Treatment (Paclitaxel With or Without Bevacizumab) in Patients With Recurrent Ovarian Cancer (PHASE1, PHASE2)
- Preoperative Radiotherapy And ASTX660 in Rectum Cancer (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:
- Tolinapant CI brief — competitive landscape report
- Tolinapant updates RSS · CI watch RSS
- Taiho Oncology, Inc. portfolio CI
Frequently asked questions about Tolinapant
What is Tolinapant?
Who makes Tolinapant?
Is Tolinapant also known as anything else?
What development phase is Tolinapant in?
Related
- Manufacturer: Taiho Oncology, Inc. — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: ASTX660, 1799328-86-1, XIAP/cIAP1 Antagonist ASTX660, ASTX 660
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing