Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Mozobil | — | 2009-07-30 | europa.eu ↗ |
| Approved | US (FDA) | MOZOBIL | — | 2008-12-15 | fda.gov ↗ |
Trials 17
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2023-07-27 | Zydus Lifesciences Limited | Regulatory Zydus receives final approval from the USFDA for Plerixafor Injection USP, 24 mg/1.2 mL (20 mg/mL), Single-Dose Vial zyduslife.com ↗
Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as “Zydus”) has received final approval from the United States Food and Drug Administration (USFDA) for Plerixafor Injection, 24 mg/1.2 mL (20 mg/mL), Single -Dose Vial (USRLD: Mozobil® Injection, 24 mg/1.2 mL [20 mg/mL]). |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2023-07-27 | Zydus Lifesciences Limited | Zydus receives final approval from the USFDA for Plerixafor Injection USP, 24 mg/1.2 mL (20 mg/mL), Single-Dose Vial zyduslife.com ↗ |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 22 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | AMD3100 | “The CXCR4 antagonist plerixafor (AMD3100, Mozobil) durably reverses panleukopenia and in most WHIM patients induces wart regression;” PMID 40330596 ↗ Apr 202516“AMD3100 is a new drug that also mobilizes stem cells in large numbers within a few hours.” NCT00082329 ↗ “AMD 3100 (Mozobil Plerixafor) to Mobilize Stem Cells for Donation” NCT00075335 ↗ |
| Known as | AMD3100 (Plerixafor) | “AMD3100 (Plerixafor)” NCT01353937 ↗ |
| Known as | Mozobil | “This is a pilot (phase 1) study of AMD3100(also called Plerixafor, Mozobil).” NCT01655875 ↗9“AMD 3100 (Mozobil Plerixafor) to Mobilize Stem Cells for Donation” NCT00075335 ↗ “subcutaneous AMD3100 (Plerixafor/Mozobil®)” NCT01353937 ↗ “AMD 3100 (Mozobil plerixafor)” NCT00082329 ↗ |
| Known as | plerixafor | “Mozobil (Plerixafor): 0,24 mg/kg daily. When CD34+ are ≥ 10 /μL Plerixafor will be administered subcutaneously from the next day (or from day 24 if CD34+ are \< 10 /μL) to the...” NCT03055247 ↗5“The objective of this study is to perform a prospective randomized, controlled trial to evaluate the response of the endometrial lining after subcutaneous administration of...” NCT04045821 ↗ “This is a pilot (phase 1) study of AMD3100(also called Plerixafor, Mozobil).” NCT01655875 ↗ “AMD 3100 (Mozobil Plerixafor) to Mobilize Stem Cells for Donation” NCT00075335 ↗ “Mozobil (TM) (plerixafor injection, Genzyme/Sanofi)” NCT00967785 ↗ “AMD 3100 (Mozobil plerixafor)” NCT00082329 ↗ |
| Action | Inhibit | “inhibits the binding of stromal cell derived factor-1 (SDF-1) to its cognate receptor CXC- chemokine receptor 4 (CXCR4)” NCT00075335 ↗ |
| Modality | Small molecule | “AMD3100, is a bicyclam compound” NCT00075335 ↗ |
| Route | Subcutaneous | “single subcutaneous injection of AMD3100” NCT00075335 ↗ |
| Target | CXCR4 | “AMD3100 reversibly inhibits CXC- chemokine receptor 4 (CXCR4) binding” NCT00082329 ↗ |