Drugs / Ponatinib
Regulatory milestones approvals, filings & regulatory actions · 8 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (6) | US (FDA) | ICLUSIG | — | 2016-06-02 – 2025-10-10 | fda.gov ↗ |
| Approved | EU (EMA) | Iclusig | — | 2013-07-01 | europa.eu ↗ |
| Approved | US (FDA) | ICLUSIG | — | 2012-12-14 | fda.gov ↗ |
Trials 65 · started per year
today
US approved 2012
EU approved 2013
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Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT01838642 Comparator | Mar 2013 → Dec 2015 | thyroid cancer | National Institutes of Health Clinical Center (CC) | Terminated | No outcome recorded |
Press releases naming this drug 14 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-03-27 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Submits Application in Japan for Iclusig for First-Line Treatment of Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia® otsuka.co.jp ↗ |
| 2024-03-19 | Takeda | Takeda Announces U.S. FDA Approval of Supplemental New Drug Application (sNDA) for ICLUSIG® (ponatinib) in Adult Patients with Newly Diagnosed Ph+ ALL takeda.com ↗ |
| 2022-11-17 | Takeda | Phase 3 Trial of ICLUSIG ® (ponatinib) Met Primary Endpoint in Newly-Diagnosed Ph+ ALL, a Setting with No Targeted Treatments Approved in the US takeda.com ↗ |
| 2021-05-20 | Incyte Corporation | Positive Primary Analysis from the Phase 2 OPTIC Study of Ponatinib (Iclusig®) in Chronic Phase-Chronic Myeloid Leukemia (CP-CML) to be Presented at the 2021 ASCO Annual Meeting incyte.com ↗ |
| 2021-05-19 | Takeda | Takeda to Present Positive Primary Analysis from Phase 2 OPTIC Trial of ICLUSIG® (ponatinib), Reinforcing Ability to Address Gaps in Care for Chronic-Phase CML takeda.com ↗ |
| 2020-12-18 | Takeda | U.S. FDA Approves Supplemental New Drug Application for Takeda’s ICLUSIG ® (ponatinib) for Adult Patients with Resistant or Intolerant Chronic-Phase CML takeda.com ↗ |
| 2020-05-29 | Takeda | Takeda to Present Data from the ICLUSIG ® (ponatinib) Clinical Trial Program that Could Prove Practice-Changing for the Treatment of Chronic-Phase CML takeda.com ↗ |
| 2020-05-29 | Incyte Corporation | Interim Data from the Open Label Phase 2 OPTIC Study of Iclusig® (ponatinib) for Chronic Phase-CML Presented at the ASCO and EHA Virtual Meetings incyte.com ↗ |
| 2018-03-22 | Takeda | Takeda Announces Publication of Final Data from ICLUSIG ® (ponatinib) Pivotal Phase 2 PACE Trial in Blood takeda.com ↗ |
| 2016-11-18 | Otsuka Pharmaceutical Development & Commercialization, Inc. | ICLUSIG Tablets 15 mg Now Available in Japan for Patients with Chronic Myeloid Leukemia and Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia® otsuka.co.jp ↗ |
| 2016-09-28 | Otsuka Pharmaceutical Development & Commercialization, Inc. | ICLUSIG Tablets 15 mg Approved in Japan for Patients with Chronic Myeloid Leukemia and Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia® otsuka.co.jp ↗ |
| 2016-05-09 | Incyte Corporation | Incyte and ARIAD Announce Agreement for Incyte to Acquire ARIAD’s European Operations and In-license Iclusig® (ponatinib) in Europe incyte.com ↗ |
| 2016-01-08 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka and ARIAD Announce New Drug Application for Ponatinib Submitted in Japan for the Treatment of Refractory Leukemia otsuka.co.jp ↗ |
| 2014-12-23 | Otsuka Pharmaceutical Development & Commercialization, Inc. | ARIAD and Otsuka Announced Co-development and Commercialization Agreement for Iclusig to Treat Leukemias in Japan and Nine Other Asian Countries ® otsuka.co.jp ↗ |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 69 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ponatinib | “Imatinib was initiated at a dose of 200mg/d, dasatinib at a dose of 50mg/d, and ponatinib at a dose of 30mg/d.” NCT03624530 ↗64“Ponatinib is a drug, taken by mouth, that targets and kills leukemia cells that have the BCR-ABL mutation.” NCT07301424 ↗ “If the patients had T315I mutations, ponatinib will be given.” NCT01883219 ↗ “Pentostatin Ponatinib Pralatrexate” NCT02551718 ↗ |
| Known as | AP-24534 HCL | ChEMBL registry synonym — accepted as the source's own label CHEMBL1171837 ↗ |
| Known as | AP24534 | “Ponatinib (AP24534) is a potent oral tyrosine kinase inhibitor that blocks native and mutated BCR-ABL, including the gatekeeper mutant T315I, which is uniformly resistant to...” PMID 23190221 ↗ Nov 20122“Ponatinib (AP24534) is a third generation tyrosine kinase inhibitor targeting the BCR-ABL tyrosine kinase domain.” NCT02428543 ↗ “Expanded Access Program of Ponatinib (AP24534)” NCT01592136 ↗ |
| Known as | ICLUSIG | “In the Phpos ALL subset, the third-generation tyrosine kinase inhibitor ponatinib (PONA, Iclusig®, Incyte) has also been evaluated frontline with promising results when...” NCT06860269 ↗2“Ponatinib (Iclusig®) : Tyrosine Kinase Inhibitor (BCR-ABL); oral (tablets) : 30mg/day during 6 months (induction phase)” NCT04070443 ↗ “patients will receive a dosage of 15 mg of ICLUSIG (ponatinib).” NCT05306301 ↗ |
| Known as | PONA | “In the Phpos ALL subset, the third-generation tyrosine kinase inhibitor ponatinib (PONA, Iclusig®, Incyte) has also been evaluated frontline with promising results when...” NCT06860269 ↗ |
| Known as | Ponatinib Hydrochloride | “Ponatinib Hydrochloride as Second Line Therapy in Treating Patients With Chronic Myeloid Leukemia in Chronic Phase Resistant or Intolerant to Imatinib Mesylate, Dasatinib, or Nilotinib” NCT01746836 ↗ |
| Action | Inhibit | “Ponatinib (AP24534) is a potent oral tyrosine kinase inhibitor that blocks native and mutated BCR-ABL, including the gatekeeper mutant T315I, which is uniformly resistant to...” PMID 23190221 ↗ Nov 2012 |
| Modality | Small molecule | “Ponatinib is a novel synthetic orally active tyrosine kinase inhibitor (TKI)” NCT01641107 ↗ |
| Route | Oral | “administered ponatinib 45 mg, tablet, orally” NCT01207440 ↗ |
| Target | ABL1 | “The BCR-ABL1 inhibitor ponatinib is approved for the treatment of adults with chronic myeloid leukemia or Philadelphia chromosome-positive acute lymphoblastic leukemia,...” PMID 34699069 ↗ Dec 2021 |