Drugs / Ponatinib
Regulatory milestones approvals, filings & regulatory actions · 11 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed B-lymphoblastic leukemia/lymphoma with t(9;22)(q34.1;q11.2) 1 milestone | |||||
| Filed | Japan (PMDA) | Iclusig | B-lymphoblastic leukemia/lymphoma with t(9;22)(q34.1;q11.2) | 2026-03-27 | “application in Japan seeking regulatory approval for an expanded indication of Iclusig (ponatinib hydrochloride) to include first-line treatment of Philadelphia...” otsuka.co.jp ↗ |
| Filed Philadelphia-positive myelogenous leukemia 2 milestones | |||||
| Filed | Japan (PMDA) | Iclusig | Philadelphia-positive myelogenous leukemia | 2016-01-08 | “The New Drug Application (NDA) for ponatinib was filed in Japan for the first time as a novel oral treatment for chronic myeloid leukemia (CML)” otsuka.co.jp ↗ |
| Filed | Other | Iclusig | Philadelphia-positive myelogenous leukemia | — | “NDAs have been submitted in Korea and Taiwan as well.” otsuka.co.jp ↗ |
| Approved Indication not stated 3 milestones | |||||
| 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
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US approved 2012
EU approved 2013
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News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2026-03-27 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory 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 | Regulatory 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 ↗
Takeda ( TSE:4502/NYSE:TAK ) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for ICLUSIG ® (ponatinib) for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy. |
| 2022-11-17 | Takeda | Results 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 ↗
Primary Endpoint Result Shows Superiority Compared to Imatinib as Assessed by MRD-Negative Complete Remission |
| 2021-05-20 | Incyte Corporation | Results 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 ↗
The results show that the optimal benefit-risk profile for ponatinib in patients with CP-CML was achieved with a starting dose of 45mg/day, and upon response (achieving ≤1% BCR-ABL1IS), dose reduction to 15mg/day. |
| 2021-05-19 | Takeda | Results 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 ↗
The OPTIC trial, which evaluated treatment in patients with resistant disease, with and without mutations, met its primary endpoint. |
| 2020-12-18 | Takeda | Regulatory 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 | Results 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 ↗
This dosing regimen resulted in an adjudicated arterial occlusive event (AOE) rate of 5.3%. |
| 2020-05-29 | Incyte Corporation | Results 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 ↗
Data from the interim analysis of the Phase 2 OPTIC trial show that response-based dosing regimens of Iclusig can optimize benefit-risk profile in patients with resistant or intolerant chronic phase-chronic myeloid leukemia (CML) |
| 2018-03-22 | Takeda | Results Takeda Announces Publication of Final Data from ICLUSIG ® (ponatinib) Pivotal Phase 2 PACE Trial in Blood takeda.com ↗
The final five-year results support ICLUSIG as an effective treatment option for patients with chronic-phase CML (CP-CML) whose prior therapies have failed. |
| 2016-09-28 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory ICLUSIG Tablets 15 mg Approved in Japan for Patients with Chronic Myeloid Leukemia and Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia® otsuka.co.jp ↗
ICLUSIG, an oral tyrosine kinase inhibitor (TKI) discovered by ARIAD Pharmaceuticals, Inc. and indicated for chronic myeloid leukemia (CML) and Philadelphia Chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), has been approved in Japan. |
| 2016-01-08 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Otsuka and ARIAD Announce New Drug Application for Ponatinib Submitted in Japan for the Treatment of Refractory Leukemia otsuka.co.jp ↗
The New Drug Application (NDA) for ponatinib was filed in Japan for the first time as a novel oral treatment for chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL). |
All press releases naming this drug 14 releases
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 |