THERAPY DOSSIER · th-ace9bb1449c4

Tanezumab

Biologic · Humanised monoclonal antibody that sequesters beta-nerve growth factor (target CHEMBL1649058); action type INHIBITOR, direct interaction true, disease efficacy true. ATC N02BG12. Not approved; ChEMBL max_phase 3.

Not approved Suggest a correction

Evidence & regulatory context

Mechanism: Humanised monoclonal antibody that sequesters beta-nerve growth factor (target CHEMBL1649058); action type INHIBITOR, direct interaction true, disease efficacy true. ATC N02BG12. Not approved; ChEMBL max_phase 3.
Target: CHEMBL1649058
Injury models: Other · Burn · Spinal cord injury
Reported indication: Not recorded
First approval: Not recorded
Development stage: In trials, not approved
ChEMBL record: CHEMBL2108567 ↗
ChEMBL max phase: 3 / 4 (development scale, not regulatory approval)
Synonyms: Tanezumab; PF-04383119; PF-4383119; RN-624; RN624
Note: Not recorded

Clinical trials 10

0 linked trials carry an injury-indication flag. These flags support record-level exploration and sit alongside the stringent aggregate counts described in Methods.

NCT02528188 ↗PHASE3completed

Phase 3 Long-Term Safety/Efficacy of SC Tanezumab in Hip/Knee OA

Chronic Pain · Osteoarthritis, Hip · Osteoarthritis, Knee

Enrolment: 3021 · Results not recorded

NCT00744471 ↗PHASE3completed

Phase 3 Analgesic Efficacy/Safety of Tanezumab in Hip OA

Arthritis · Osteoarthritis · Osteoarthritis, Hip

Enrolment: 627 · Results not recorded

NCT02609828 ↗PHASE3completed

Phase 3 SC Tanezumab in Cancer Pain Due to Bone Metastasis

Bone Metastasis · Cancer Pain

Enrolment: 156 · Results not recorded

NCT00863772 ↗PHASE3terminated

Phase 3 Tanezumab on Peripheral Nerve Function in OA

Osteoarthritis

Enrolment: 220 · Results not recorded

NCT00924664 ↗PHASE2terminated

Long Term Safety of Tanezumab in Chronic Low Back Pain

Low Back Pain

Enrolment: 849 · Results not recorded

NCT00994890 ↗PHASE2terminated

Long Term Safety of SC Tanezumab in Knee/Hip OA

Osteoarthritis, Knee · Osteoarthritis, Hip

Enrolment: 679 · Results not recorded

NCT00999518 ↗PHASE2terminated

Phase 2b Tanezumab for Interstitial Cystitis/Painful Bladder Syndrome

Cystitis, Interstitial

Enrolment: 205 · Results not recorded

NCT00669409 ↗PHASE2completed

Phase 1/2a Single IV PF-04383119 in Japanese Knee OA Pain

Osteoarthritis, Knee

Enrolment: 83 · Results not recorded

NCT00399490 ↗PHASE2completed

Open-Label Multiple-Dose RN624 in Knee OA Pain

Osteoarthritis · OA Knee Pain · Arthritis

Enrolment: 287 · Results not recorded

NCT01030640 ↗PHASE1completed

Phase 1 Intraepidermal Nerve Fiber Density After SC Tanezumab in HV

Osteoarthritis Pain · Chronic Low Back Pain · Pain Due to Interstitial Cystitis

Enrolment: 28 · Results not recorded

Preclinical evidence 3

1 studies reported at therapy level; 3 evidence entries itemised.

PMID 27381034 ↗2016Reported harm

Nerve growth factor inhibition with tanezumab influences weight-bearing and subsequent cartilage damage in the rat medial meniscal tear model.

RatOtherLewisMalen = n=10 rats per group for histopathology; amputation study in…Subcutaneous0.1, 1 or 10 mg/kg per weekProphylactic arm started on the day of surgery (day 0); delayed-onset arm start…

Model: Medial meniscal tear (MMT) surgery of the knee, with additional delayed-treatment and mid-tibial amputation arms

Prophylactic tanezumab prevented the gait deficiency seen 3 to 7 days after MMT surgery and produced more severe cartilage damage, larger osteophytes, greater subchondral sclerosis and increased growth plate thickness in a time and dose related manner. Delaying treatment to 3 to 8 weeks after surge…

Extraction: extract · Supplied extraction confidence: 0.9. Machine-extracted fields require source verification.

PMID 12133564 ↗2002

Nerve growth factor induces systemic hyperalgesia after thoracic burn injury in the rat

RatBurn

Extraction: mesh. Machine-extracted fields require source verification.

PMID 9344570 ↗1997

Spinal cord injury and anti-NGF treatment results in changes in CGRP density and distribution in the dorsal horn in the rat

RatSpinal cord injury

Extraction: mesh. Machine-extracted fields require source verification.

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