Summary
Labetalol has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in ADHD would be drug repurposing rather than first-in-human development. This does not mean it is approved for ADHD. ClinicalTrials.gov lists 1 registered trial linking Labetalol to ADHD: 1 is currently recruiting. None of the registered studies carries a drug-development phase label, which is typical for behavioural, device and supplement protocols. It plans or enrolled 5000 participants. Registered activity dates to 2020. The literature layer holds 1 publication for this pair: 1 Cochrane review. The dated items are from 2017. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for Attention Deficit-Hyperactivity Disorder ranks 305 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Spontaneous remission by adulthood: 30-70% symptom reduction (depending on definition); functionally impairing ADHD persists into adulthood in 50-65% of childhood cases; DSMIV criteria met in adulthood in ~50%.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 28.0 (trials 3.0, literature 5.0, tier 15, approved bonus 5.0) |
| Registered trials | 1 total: 1 recruiting, 0 active / not yet recruiting, 0 completed, 0 other |
| Linked publications | 1 (1 Cochrane review) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | DGIdb |
| Linked via biomarker / target | ADRA2C |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT04278404 | Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS) 2020 | recruiting | Not applicable | 5,000 |
Published literature
- Cochrane review In-utero exposure to antihypertensive medication and neonatal and child health outcomes: a systematic reviewFitton CA, Steiner MFC, Aucott L et al. · Journal of hypertension · 2017 · PMID 28661961
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target ADRA2C. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Labetalol approved for ADHD?
Labetalol has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in ADHD would be drug repurposing rather than first-in-human development. This does not mean it is approved for ADHD. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Labetalol in clinical trials for ADHD?
ClinicalTrials.gov lists 1 registered trial linking Labetalol to ADHD: 1 is currently recruiting. None of the registered studies carries a drug-development phase label, which is typical for behavioural, device and supplement protocols. It plans or enrolled 5000 participants. Registered activity dates to 2020.
What does the evidence show for Labetalol in ADHD?
Trials of Labetalol in ADHD are registered but none has completed, so there is no outcome evidence from those studies yet; the record is a signal of research interest. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target ADRA2C. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.