Copanlisib
Small molecule targets PIK3CA, PIK3CD via inhibition
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed marginal zone lymphoma 1 milestone | |||||
| Filed | EU (EMA) | — | marginal zone lymphoma | 2021-06-21 | “In the EU, Bayer has filed for relapsed marginal zone lymphoma (MZL), a subtype of iNHL, and the filing has been accepted” bayer.com ↗ “The U.S. and EU submissions of the novel combination of copanlisib and rituximab” bayer.com ↗ |
| Filed relapsed/refractory diffuse large B-cell lymphoma 1 milestone | |||||
| Filed | US (FDA) | — | relapsed/refractory diffuse large B-cell lymphoma | 2021-06-21 | “In the US, Bayer has filed for relapsed indolent B-cell non-Hodgkin’s lymphoma (B-iNHL)” bayer.com ↗ “The U.S. and EU submissions of the novel combination of copanlisib and rituximab” bayer.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | US (FDA) | ALIQOPA | — | 2017-09-14 | fda.gov ↗ |
Trials 73 · started per year
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2021-06-21 | Bayer | Regulatory Bayer submits regulatory applications for oncology treatment combination of copanlisib and rituximab in the U.S. and EU bayer.com ↗
In the EU, Bayer has filed for the treatment of relapsed marginal zone lymphoma (MZL), a subtype of iNHL, and the filing has been accepted. |
| 2021-04-10 | Bayer | Results Combination of copanlisib and rituximab significantly increases progression-free survival in patients with relapsed indolent non-Hodgkin's Lymphoma bayer.com ↗
Results from the randomized, double-blind, placebo-controlled Phase III trial CHRONOS-3 show a significant progression-free survival (PFS) benefit for the combination of copanlisib, the only pan class I phosphatidylinositol-3-kinase (PI3K) inhibitor, and rituximab in patients with relapsed indolent non-Hodgkin’s Lymphoma (iNHL). |
| 2020-10-14 | Bayer | Results Combination of copanlisib and rituximab significantly prolonged progression-free survival of patients with relapsed indolent non-Hodgkin's Lymphoma bayer.com ↗ |
| 2017-09-14 | Bayer | Regulatory Bayer receives FDA approval for Copanlisib in adults with relapsed follicular lymphoma after two prior systemic therapies bayer.com ↗
Bayer announced today that the U.S. Food and Drug Administration (FDA) has approved copanlisib under the brand name Aliqopa™ 60 mg vial for injection for the treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies. |
All press releases naming this drug 4 releases
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 76 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Copanlisib | “A Phase I study of intravenous PI3K inhibitor copanlisib in Japanese patients with advanced or refractory solid tumors.” PMID 27915408 ↗ Dec 201673“PI3 (Phosphatidylinositol-3)-Kinase Inhibitor Copanlisib” NCT01460537 ↗ |
| Known as | ALIQOPA | “Copanlisib (Aliqopa, BAY80-6946) solution for IV infusion (test drug/investigational medicinal product)” NCT02391116 ↗7“Copanlisib (ALIQOPA, BAY80-6946)” NCT03172884 ↗ “Copanlisib (Aliqopa, BAY80-6946)” NCT01660451 ↗ “Copanlisib (Aliqopa, BAY80-6946)” NCT03655301 ↗ “Copanlisib (Aliqopa, BAY80-6946)” NCT00962611 ↗ “Copanlisib (Aliqopa, BAY80-6946)” NCT06238583 ↗ “Copanlisib (Aliqopa, BAY80-6946)” NCT02367040 ↗ “Copanlisib (Aliqopa, BAY80-6946)” NCT03498430 ↗ |
| Known as | BAY 80-6946 | “Copanlisib (BAY 80-6946), a highly selective and potent class-1 PI3K inhibitor with sub-nanomolar IC50s against PI3Kα and PI3Kδ, has demonstrated activity in...” NCT03052933 ↗19“Copanlisib (Aliqopa, BAY80-6946) solution for IV infusion (test drug/investigational medicinal product)” NCT02391116 ↗ “effect of Rifampin on the pharmacokinetics of Copanlisib (BAY 80-6946) and safety” NCT02253420 ↗ “First-in-human phase I study of copanlisib (BAY 80-6946), an intravenous” PMID 27672108 ↗ Oct 2016 “Copanlisib (Aliqopa, BAY80-6946)” NCT01660451 ↗ “Copanlisib (Aliqopa, BAY80-6946)” NCT00962611 ↗ “Copanlisib (ALIQOPA, BAY80-6946)” NCT03172884 ↗ “Copanlisib (Aliqopa, BAY80-6946)” NCT03655301 ↗ “Copanlisib (Aliqopa, BAY80-6946)” NCT06238583 ↗ “Copanlisib (Aliqopa, BAY80-6946)” NCT02367040 ↗ “Copanlisib (Aliqopa, BAY80-6946)” NCT03498430 ↗ |
| Known as | BAY 80-6946 DIHYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL3218576 ↗ |
| Known as | BAY 84-1236 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3218576 ↗ |
| Known as | Copa | “Copanlisib (Copa): 60 mg/day i.v. on days 1,8,15” NCT04433182 ↗ |
| Known as | Copanlisib dihydrochloride | ChEMBL registry synonym — accepted as the source's own label CHEMBL3218576 ↗ |
| Known as | Copanlisib Hydrochloride | “Drug: Copanlisib Hydrochloride” NCT03939897 ↗1“Drug: Copanlisib Hydrochloride” NCT04939272 ↗ |
| Known as | Copanlisib hydrochloride hydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL3218576 ↗ |
| Action | Inhibit | “a phosphatidylinositol 3-kinase inhibitor” PMID 27672108 ↗ Oct 20162“PI3-kinase p110-delta subunit inhibitor” CHEMBL3218576 ↗ “PI3-kinase p110-alpha subunit inhibitor” CHEMBL3218576 ↗ |
| Modality | Small molecule | “Copanlisib is a small molecule pan-class 1 PI3K inhibitor” NCT04263584 ↗ |
| Route | Intravenous | “Patients received three weekly intravenous infusions of copanlisib” PMID 27672108 ↗ Oct 2016 |
| Target | PIK3CA | “PI3-kinase p110-alpha subunit inhibitor” CHEMBL3218576 ↗ |
| Target | PIK3CD | “PI3-kinase p110-delta subunit inhibitor” CHEMBL3218576 ↗ |