TheraRadar
Data updated: May 26, 2026

APHEXDA (motixafortide acetate)

Orphan Drug
Oncology Approved 2023-09-08

Aphexda helps patients with multiple myeloma by moving hematopoietic stem cells from the bone marrow into the bloodstream. It is used in combination with filgrastim to prepare these cells for collection and later autologous transplantation. This process ensures that a sufficient number of stem cells are available in the peripheral blood to be harvested for the patient's treatment.

Source: FDA Label • AYRMID PHARMA

How APHEXDA Works

This drug works by blocking the CXCR4 receptor, which prevents it from binding to a signaling molecule that normally anchors stem cells inside the bone marrow matrix. By interrupting this bond, the medication triggers the release of hematopoietic stem and progenitor cells into the peripheral circulation. This results in an increase of circulating cells that can then be effectively collected for transplantation.

1
Indication
--
Phase 3 Trials
2
Years on Market

Details

Status
Prescription
First Approved
2023-09-08
Patent Cliff
2041

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Routes
SUBCUTANEOUS
Dosage Forms
POWDER

Companies

Active Ingredient: MOTIXAFORTIDE ACETATE

APHEXDA Approval History

2024
2025
2026
Original
New Indication
New Form
Label Update
2 FDA actions from 2023 to 2026
Mar 2026 SUPPL
Label · Labeling
Sep 2023 ORIGINAL
New Drug · Type 1 - New Molecular Entity

What APHEXDA Treats

1 indications

APHEXDA is approved for 1 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Multiple Myeloma
Source: FDA Label

APHEXDA Competitive Set

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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

What's emerging in APHEXDA's indications

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Phase 3 candidates targeting molecules with no FDA-approved drug, in indications APHEXDA treats. First-in-class if their pivotal trials read out positive.

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Active Pipeline

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Key Completed Trials

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Trial Timeline

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

APHEXDA FDA Label Details

Indications & Usage

FDA Label (PDF)

APHEXDA is indicated for the treatment of Multiple Myeloma.

View full patent landscape →
2 OB patents · 1 families · 19 international docs across 10 countries

APHEXDA Patents & Exclusivity

Latest Patent: Dec 2041
Exclusivity: Sep 2030

Patents (2 active)

US12257285 Expires Dec 29, 2041
US12268725 Expires Dec 29, 2041

Exclusivity

NCE Until Sep 2028
ODE-442 Until Sep 2030
Source: FDA Orange Book

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Revenue Insights

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Patent Timeline

  • Cliff: 2041
  • 2 active patents

Trial Analysis

  • Clinical trial tracking
  • Development stage analysis

Competitive Landscape

  • 20 similar drugs
  • Same target/indication analysis
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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.