TRIAL RESULTS · SIDE EFFECTS
Motixafortide side effects
ANSWER
In 1 placebo-controlled trial with posted results, the most common side effects of Motixafortide were leukocytosis 98.6% (placebo 0.0%), injection site pain 93.2% (placebo 27.8%), injection site erythema 78.1% (placebo 11.1%). Read from ClinicalTrials.gov on 2026-10-03. Not medical advice.
Trial register
Trials with posted results
1
with an arm on Motixafortide, of 11 registered
Against placebo
1
placebo-controlled trials
People in those trials
73
on Motixafortide · 36 on placebo
Read
2026-10-03
ClinicalTrials.gov
VS PLACEBO
Most common side effects, Motixafortide beside placebo
Share of people with each side effect in 1 placebo-controlled trial with posted results: 73 people on Motixafortide (all doses), 36 on placebo, same trials. Listed only when reported for at least half of the people on Motixafortide. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
ALL TRIALS
All 63 side effects reported
Every trial with posted results and an arm on Motixafortide (n ≥ 20), all phases, by people affected. Placebo is shown where placebo-controlled trials reported the same event. Comparator arms are not counted.
| Side effect | Organ system | Motixafortide | Placebo | Trials |
|---|---|---|---|---|
| Leukocytosis | Blood and lymphatic system disorders | 98.6% (72 of 73) | 0.0% | 1 |
| Injection site pain | General disorders | 93.2% (68 of 73) | 27.8% | 1 |
| Injection site erythema | General disorders | 78.1% (57 of 73) | 11.1% | 1 |
| Pruritus | Skin and subcutaneous tissue disorders | 61.6% (45 of 73) | 0.0% | 1 |
| Urticaria | Skin and subcutaneous tissue disorders | 49.3% (36 of 73) | 0.0% | 1 |
| Injection site pruritus | General disorders | 46.6% (34 of 73) | 8.3% | 1 |
| Flushing | Vascular disorders | 42.5% (31 of 73) | 0.0% | 1 |
| Injection site induration | General disorders | 37.0% (27 of 73) | 13.9% | 1 |
| Feeling hot | General disorders | 35.6% (26 of 73) | 0.0% | 1 |
| Paraesthesia | Nervous system disorders | 27.4% (20 of 73) | 0.0% | 1 |
| Chills | General disorders | 24.7% (18 of 73) | 2.8% | 1 |
| Tremor | Nervous system disorders | 24.7% (18 of 73) | 2.8% | 1 |
| Headache | Nervous system disorders | 21.9% (16 of 73) | 2.8% | 1 |
| Injection site discolouration | General disorders | 16.4% (12 of 73) | 5.6% | 1 |
| Nausea | Gastrointestinal disorders | 15.1% (11 of 73) | 5.6% | 1 |
| Dizziness | Nervous system disorders | 13.7% (10 of 73) | 8.3% | 1 |
| Erythema | Skin and subcutaneous tissue disorders | 12.3% (9 of 73) | 2.8% | 1 |
| Peripheral swelling | General disorders | 12.3% (9 of 73) | 2.8% | 1 |
| Muscle spasms | Musculoskeletal and connective tissue disorders | 12.3% (9 of 73) | 0.0% | 1 |
| Burning sensation | Nervous system disorders | 11.0% (8 of 73) | 0.0% | 1 |
| Vomiting | Gastrointestinal disorders | 9.6% (7 of 73) | 0.0% | 1 |
| Injection site bruising | General disorders | 9.6% (7 of 73) | 0.0% | 1 |
| Injection site mass | General disorders | 8.2% (6 of 73) | 0.0% | 1 |
| Hypoaesthesia | Nervous system disorders | 8.2% (6 of 73) | 0.0% | 1 |
| Pain | General disorders | 8.2% (6 of 73) | 0.0% | 1 |
| Injection site oedema | General disorders | 6.8% (5 of 73) | 2.8% | 1 |
| Muscle twitching | Musculoskeletal and connective tissue disorders | 5.5% (4 of 73) | 0.0% | 1 |
| Myalgia | Musculoskeletal and connective tissue disorders | 5.5% (4 of 73) | 0.0% | 1 |
| Injection site warmth | General disorders | 5.5% (4 of 73) | 2.8% | 1 |
| Taste disorder | Nervous system disorders | 5.5% (4 of 73) | 0.0% | 1 |
| Hypoaesthesia oral | Gastrointestinal disorders | 5.5% (4 of 73) | 0.0% | 1 |
| Injection site swelling | General disorders | 4.1% (3 of 73) | 0.0% | 1 |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | 4.1% (3 of 73) | 0.0% | 1 |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | 4.1% (3 of 73) | 0.0% | 1 |
| Micturition urgency | Renal and urinary disorders | 4.1% (3 of 73) | 0.0% | 1 |
| Insomnia | Psychiatric disorders | 4.1% (3 of 73) | 0.0% | 1 |
| Palpitations | Cardiac disorders | 4.1% (3 of 73) | 0.0% | 1 |
| Back pain | Musculoskeletal and connective tissue disorders | 4.1% (3 of 73) | 2.8% | 1 |
| Abdominal pain | Gastrointestinal disorders | 2.7% (2 of 73) | 0.0% | 1 |
| Injection site hypoaesthesia | General disorders | 2.7% (2 of 73) | 2.8% | 1 |
| Neck pain | Musculoskeletal and connective tissue disorders | 2.7% (2 of 73) | 0.0% | 1 |
| Urinary incontinence | Renal and urinary disorders | 2.7% (2 of 73) | 0.0% | 1 |
| Piloerection | Skin and subcutaneous tissue disorders | 2.7% (2 of 73) | 0.0% | 1 |
| Rash | Skin and subcutaneous tissue disorders | 2.7% (2 of 73) | 0.0% | 1 |
| Rash erythematous | Skin and subcutaneous tissue disorders | 2.7% (2 of 73) | 0.0% | 1 |
| Constipation | Gastrointestinal disorders | 2.7% (2 of 73) | 5.6% | 1 |
| Injection site haemorrhage | General disorders | 2.7% (2 of 73) | 0.0% | 1 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 2.7% (2 of 73) | 0.0% | 1 |
| Presyncope | Nervous system disorders | 2.7% (2 of 73) | 0.0% | 1 |
| Dermatitis contact | Skin and subcutaneous tissue disorders | 2.7% (2 of 73) | 5.6% | 1 |
| Ear discomfort | Ear and labyrinth disorders | 2.7% (2 of 73) | 0.0% | 1 |
| Alopecia | Skin and subcutaneous tissue disorders | 2.7% (2 of 73) | 0.0% | 1 |
| Dry skin | Skin and subcutaneous tissue disorders | 2.7% (2 of 73) | 5.6% | 1 |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 2.7% (2 of 73) | 0.0% | 1 |
| Fatigue | General disorders | 2.7% (2 of 73) | 0.0% | 1 |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 2.7% (2 of 73) | 0.0% | 1 |
| Injection site necrosis | General disorders | 2.7% (2 of 73) | 0.0% | 1 |
| Haematochezia | Gastrointestinal disorders | 1.4% (1 of 73) | 2.8% | 1 |
| Somnolence | Nervous system disorders | 1.4% (1 of 73) | 0.0% | 1 |
| Weight decreased | Investigations | 1.4% (1 of 73) | 5.6% | 1 |
| Asthenia | General disorders | 1.4% (1 of 73) | 2.8% | 1 |
| Dermatitis | Skin and subcutaneous tissue disorders | 1.4% (1 of 73) | 2.8% | 1 |
| Acne | Skin and subcutaneous tissue disorders | 0.0% (0 of 73) | 2.8% | 1 |
Source: ClinicalTrials.gov posted results, read 2026-10-03. A trial lists events above its own reporting threshold, so a rare event may be missing from some trials. Not medical advice.
FDA LABEL
What the FDA label says
APHEXDA NDA217159 · label of 2026-06-04 Regulator
Most common adverse reactions (incidence >20%) are injection site reactions, injection site pain, injection site erythema, injection site pruritus, pruritus, flushing, and back pain.
QUESTIONS
Does motixafortide cause leukocytosis?
In 1 placebo-controlled trial with posted results, 98.6% of people on motixafortide reported leukocytosis, against 0.0% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does motixafortide cause injection site pain?
In 1 placebo-controlled trial with posted results, 93.2% of people on motixafortide reported injection site pain, against 27.8% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does motixafortide cause injection site erythema?
In 1 placebo-controlled trial with posted results, 78.1% of people on motixafortide reported injection site erythema, against 11.1% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does motixafortide cause pruritus?
In 1 placebo-controlled trial with posted results, 61.6% of people on motixafortide reported pruritus, against 0.0% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does motixafortide cause urticaria?
In 1 placebo-controlled trial with posted results, 49.3% of people on motixafortide reported urticaria, against 0.0% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
REGISTERED STUDIES
11 registered clinical trials of Motixafortide
The 10 most recently updated are listed.
| NCT04543071 | Chemo4METPANC Combination Chemokine Inhibitor, Immunotherapy, and Chemotherapy in Pancreatic Adenocarcinoma Status: ACTIVE_NOT_RECRUITING · Updated 2026-09-21 |
|---|---|
| NCT06514508 | Mobilization of Stem Cells With Motixafortide (BL-8040) in Combination With G-CSF in Multiple Myeloma Patients Status: RECRUITING · Updated 2026-09-14 |
| NCT06442761 | SCD Stem Cell Mobilization and Apheresis Using Motixafortide Status: RECRUITING · Updated 2026-09-08 |
| 2024-511953-23-00 | A Phase III, Randomized, Double-Blinded, Placebo-Controlled, Multi-Centre Study Evaluating the Safety, Tolerability and Efficacy of Combination Treatment of BL-8040 and G-CSF as Compared to Placebo and G-CSF for the Mobilization of Hematopoietic Stem Cells for Autologous Transplantation in Subjects with Multiple Myeloma - The GENESIS Study Status: UNKNOWN · Updated 2026-07-29 |
| NCT07392970 | Motixafortide for MRD Sensitization in AML Status: RECRUITING · Updated 2026-07-24 |
| NCT07101445 | Evaluating Premedication Regimens (Methylprednisolone vs Dexamethasone-based) for the Prevention of Systemic and Injection Site Reactions to Motixafortide in Patients With Multiple Myeloma Undergoing Stem Cell Mobilization, PARADE Trial Status: RECRUITING · Updated 2026-07-23 |
| NCT06506461 | Gene Editing For Sickle Cell Disease Status: RECRUITING · Updated 2026-05-05 |
| NCT06547112 | A Pharmacodynamic Study of the Apheresis Product of Multiple Myeloma Patients Undergoing Quad-induction Followed by Motixafortide + G-CSF Mobilization Status: COMPLETED · Updated 2025-08-29 |
| NCT05618301 | Motixafortide and Natalizumab to Mobilize CD34+ Hematopoietic Stem Cells for Gene Therapies in Sickle Cell Disease (SCD) Status: COMPLETED · Updated 2025-08-11 |
| NCT05293171 | Study to Investigate the Effect of BL-8040 (Motixafortide) on the QTc Interval in Healthy Subjects Status: COMPLETED · Updated 2025-03-21 |
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