Drugs / Calmangafodipir
Calmangafodipir
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Clinical hold | US (FDA) | PledOx | chemotherapy-induced neuropathy | — | “In January, the US FDA issued a clinical hold in the US on the POLAR program” egetis.com ↗ “FDA issued a clinical hold in the US of the phase III POLAR-M study” egetis.com ↗ |
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT03430999 | Nov → Dec 2017 | chemotherapy-induced neuropathy | Egetis Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT03177395 | Jun 2017 → Aug 2018 | paracetamol poisoning | Egetis Therapeutics | Completed | No outcome recorded |
| Phase 32 trials · 2 missed | ||||||
| Phase 3 | NCT04034355 | Jan 2019 → Aug 2020 | chemotherapy-induced neuropathy, colorectal cancer | Egetis Therapeutics | Terminated | Missed primary Stop: Enrollment |
| Phase 3 | NCT03654729 | Nov 2018 → Aug 2020 | chemotherapy-induced neuropathy, colorectal cancer | Egetis Therapeutics | Terminated | Missed primary |
| Comparator or background therapy1 trial | ||||||
| Phase 1/2 | NCT01619423 Comparator | Sep 2012 → Mar 2016 | colorectal cancer | Egetis Therapeutics | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2022-07-13 | Egetis Therapeutics | Regulatory Egetis receives positive opinion on orphan designation for Aladote® from the European Medicines Agency for the Prevention of Acute Liver Failure egetis.com ↗
We are delighted to receive a positive opinion for orphan designation from EMA for Aladote for the prevention of acute liver failure. |
| 2020-12-15 | Egetis Therapeutics | Results Results from the prematurely closed PledOx POLAR program egetis.com ↗
The severe allergic-hypersensitivity reactions occurred only after repeated treatment cycles. |
| 2020-07-09 | Egetis Therapeutics | Results Positive pre-clinical results with PledOx published in Antioxidants egetis.com ↗
The preclinical oxaliplatin study confirms a protective effect of PledOx (calmangafodipir) against oxaliplatin-induced small fiber neuropathy. |
| 2020-06-26 | Egetis Therapeutics | Results Positive pre-clinical results with PledOx to be presented at Peripheral Nerve Society’s annual meeting egetis.com ↗
The preclinical oxaliplatin study confirms a protective effect of PledOx (calmangafodipir) against oxaliplatin-induced small fiber neuropathy. |
| 2020-04-06 | Egetis Therapeutics | Results PledPharma to close POLAR phase 3 program in the third quarter egetis.com ↗
However, in a meeting in March, the independent Drug Safety Monitoring Board (DSMB) for the POLAR program recommended that the program should be stopped due to a number of severe allergic reactions observed after repeated dosing. |
| 2020-03-01 | Egetis Therapeutics | Regulatory PledPharma places dosing of patients in the POLAR program on hold egetis.com ↗
Altogether, based on the views of the FDA and ANSM, PledPharma has taken a decision to place dosing of patients in the POLAR program on hold in all countries. |
| 2020-01-23 | Egetis Therapeutics | Regulatory PledPharma provides update on the clinical POLAR program, clinical hold in the US egetis.com ↗
The clinical hold of the POLAR program issued by the FDA means that recruitment and dosing of patients in the POLAR M study is halted in the US. |
| 2019-07-15 | Egetis Therapeutics | Results The Lancet EBioMedicine publishes Aladote® study results egetis.com ↗
The combination of NAC and Aladote® was safe and tolerated. |
All press releases naming this drug 12 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | calmangafodipir | “PledOx active ingredient= Calmangafodipir; FOLFOX6=Combination of FOLinic Acid, 5-Fluorouracil (5-FU), and Oxaliplatin.” NCT01619423 ↗ |
| Known as | Calmangafodipir (ca4mn(dpdp)5) | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297714 ↗ |
| Known as | CaM | “Calmangafodipir (CaM, PledOx) demonstrated efficacy in preventing patient-reported chemotherapy-induced peripheral neuropathy (CIPN) in a randomized phase 2 study in patients...” PMID 36308441 ↗ Nov 2022 |
| Known as | PledOx | “Persistent prevention of oxaliplatin-induced peripheral neuropathy using calmangafodipir (PledOx(®)): a placebo-controlled randomised phase II study (PLIANT).” PMID 29140155 ↗ Nov 2017 |
| Known as | PP100-01 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297714 ↗ |
| Modality | Small molecule | “the manganese chelate and superoxide dismutase mimetic mangafodipir (MnDPDP) and calmangafodipir ([Ca0.8,Mn0.2]Na3DPDP)” NCT03654729 ↗ |
| Route | Intravenous | “PP100-01 treatment is administered intravenously over 5 minutes.” NCT03177395 ↗ |