THERAPY DOSSIER · th-8ed0eced4b70

Phenylephrine

Drug · Adrenergic receptor alpha-1 agonist (AGONIST, direct interaction, disease efficacy true)

No trauma translation Suggest a correction

This record is classified as “NO TRAUMA TRANSLATION”. Read the indication and notes below for the specific context.

Evidence & regulatory context

Mechanism: Adrenergic receptor alpha-1 agonist (AGONIST, direct interaction, disease efficacy true)
Target: CHEMBL2094251 (adrenergic receptor alpha-1)
Injury models: Ischaemia-reperfusion
Reported indication: Hypotension/vasopressor (alpha-1 agonist) and nasal decongestant; approved 1952
First approval: 1952
Development stage: Approved vasopressor/decongestant (oral decongestant efficacy repudiated); acute-stroke use investigational
ChEMBL record: CHEMBL1215 ↗
ChEMBL max phase: 4 / 4 (development scale, not regulatory approval)
Synonyms: Phenylephrine; (R)-phenylephrine; m-Synephrine; Metasynephrine; Neo-Synephrine
Note: Not recorded

Clinical trials 2

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

NCT06770426 ↗PHASE3not yet recruiting

Carbogen with phenylephrine versus phenylephrine only in progressing cerebral infarction (CARBOGEN)

Acute Ischemic Stroke

Enrolment: 40 · Results not recorded

NCT05881915 ↗NAcompleted

Epinephrine versus phenylephrine infusion for prophylaxis against maternal hypotension after spinal anaesthesia

Hypotension During Surgery

Enrolment: 196 · Results not recorded

Preclinical evidence 1

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

PMID 22954904 ↗2012Reported benefit

Phenylephrine-induced hypertension during transient middle cerebral artery occlusion alleviates ischemic brain injury in spontaneously hypertensive rats.

RatIschaemia-reperfusionCerebral (MCAO/stroke)Spontaneously hypertensive ratMalen = n=6 per group (12 rats)Intravenous (tail vein)15-20 micrograms/kg/min titrated to mean arterial pressure…Throughout the 1 h occlusion, discontinued after reperfusion

Model: Transient (1 h) middle cerebral artery occlusion

Maintaining pre-existing hypertension significantly reduced infarct volume, oedema and neurological deficits, with higher and more rapidly restored regional cerebral blood flow.

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

Record at a glance

Study window: 2012–2012
Corpus tranches: 1980-1989 · 2011-2020
Species: Rat
Physical-trauma evidence: Not flagged
Repurposed: Approval pre-dates corpus studies
Combination: Not flagged
Withdrawal flag: Not flagged
Dataset: 2026-08-25

Safety narrative

Requires review

FDA Nonprescription Drugs Advisory Committee (Sept 2023) concluded oral phenylephrine is ineffective as a decongestant; FDA proposed removing oral OTC phenylephrine (2024)

The note concerns a different formulation, related agent, efficacy, or an insufficiently specified source. Excluded from definitive safety and setback totals pending review.

Sources & provenance

ChEMBL (EMBL-EBI) CHEMBL1215 max_phase 4, approved 1952
FDA NDAC Sept 2023 (oral phenylephrine ineffective as decongestant)
ClinicalTrials.gov (NIH/NLM) NCT06770426

How records are classified

Loading the evidence…