THERAPY DOSSIER · th-9ef29ae421a2

Dl-3-n-butylphthalide (NBP)

Drug

Evidence & regulatory context

Mechanism: Not recorded
Target: Not recorded
Injury models: Spinal cord injury · TBI
Reported indication: Not recorded
First approval: Not recorded
Development stage: In trials, not approved
ChEMBL record: CHEMBL248594 ↗
ChEMBL max phase: 3 / 4 (development scale, not regulatory approval)
Synonyms: Rac-3-n-butylphthalide
Note: Not recorded

Clinical trials 6

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

NCT04091412 ↗PHASE4unknown

Collateral Circulation in Symptomatic Intracranial Anterior Circulation Occlusion (butylphthalide)

Collateral Circulation · Large-artery Occlusion · Cerebral Infarction

Enrolment: 500 · Results not recorded

NCT06508671 ↗PHASE4not yet recruiting

DL-3-n-butylphthalide on Chemotherapy-Induced Cognitive Impairment (NBP CICI)

Chemotherapy-Related Cognitive Impairment

Enrolment: 100 · Results not recorded

NCT04205578 ↗PHASE3unknown

Dl-3-n-butylphthalide in Moyamoya After EC-IC Revascularisation

Moyamoya Disease · Ischemic Stroke · Transient Ischemic Attack

Enrolment: 450 · Results not recorded

NCT06472921 ↗PHASE2completed

Early Butylphthalide on Neural Function in Acute Ischaemic Stroke

Acute Ischemic Stroke

Enrolment: 204 · Results not recorded

NCT03906123 ↗NAunknown

DL-3-n-butylphthalide in Mild Vascular Dementia (SIVD)

Subcortical Vascular Dementia · Cerebral Small Vessel Diseases

Enrolment: 64 · Results not recorded

NCT05086874 ↗Phase not recordedcompleted

Real-world Retrospective Study of Butylphthalide in Ischaemic Stroke

Stroke · Cerebral Infarction · Brain Ischemia

Enrolment: 81292 · Results not recorded

Preclinical evidence 2

2 studies reported at therapy level; 2 evidence entries itemised.

PMID 28842949 ↗2017Reported benefit

Dl-3-n-butylphthalide attenuates acute inflammatory activation in rats with spinal cord injury by inhibiting microglial TLR4/NF-kB signalling.

RatSpinal cord injuryCompressionSprague-DawleyFemalen = n = 8 per group for behavioural endpoints and n = 5 per gro…Oral gavage80 mg/kg/day (dissolved in peanut oil); 30 microM in BV-2 c…First dose immediately after injury

Model: Traumatic spinal cord injury by T9 laminectomy and extradural compression with a vascular clip (15 g force) for 1 minute

NBP improved locomotor recovery from day 7 onwards, reduced lesion cavity area, neuronal apoptosis and TUNEL-positive cells, and suppressed microglial activation and TLR4/NF-kB-driven cytokine release both in vivo and in an LPS-stimulated BV-2 and PC12 co-culture.

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

PMID 28359729 ↗2017Reported benefit

DL-3-n-butylphthalide induced neuroprotection, regenerative repair, functional recovery and psychological benefits following traumatic brain injury in mice.

MouseTBIControlled cortical impactC57BL/6 and alpha-smooth muscle actin-GFP transgenic mice on a C57BL/6 backgroundMalen = n = 12 (injury plus saline) and n = 13 (NBP) for contusion…Intraperitoneal for the acute dose, intranasal for repeated dosing100 mg/kg intraperitoneally acutely and 100 mg/kg/day intra…Single intraperitoneal dose within 5 min after injury

Model: Controlled cortical impact under 1.5% isoflurane; 3.5 mm craniotomy 2.0 mm right of the central suture midway between lambda and bregma; 2.0 mm impact tip at 3.0 m/s, 1.0 mm depth, 150 ms contact time

Contusion volume fell from 7.32 plus or minus 0.57 to 5.83 plus or minus 0.69 (p less than 0.05, n = 12 and 13) with fewer TUNEL-positive cells at 1 and 3 days, suppressed caspase activation and reduced NF-kappaB activation, TNF-alpha and IL-1beta. Chronic intranasal treatment increased neurogenesi…

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

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