Summary
Imipramine has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Low Back Pain would be drug repurposing rather than first-in-human development. This does not mean it is approved for Low Back Pain. ClinicalTrials.gov lists 1 registered trial linking Imipramine to Low Back Pain: 1 has completed. The most advanced is Phase 3 (NCT01179828). It plans or enrolled 150 participants. Registered activity dates to 2010. The literature layer holds 5 publications for this pair: 1 Cochrane review and 4 clinical trial publications. Publication years run from 1982 to 2024. 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 Low Back Pain ranks 331 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: ~90% of acute LBP episodes resolve within 6 weeks regardless of treatment; chronic LBP (>3 months) shows only 30-40% recovery at 1 year and high recurrence; opioid prescribing correlates inversely with recovery.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 37.5 (trials 4.5, literature 13.0, tier 15, approved bonus 5.0) |
| Registered trials | 1 total: 0 recruiting, 0 active / not yet recruiting, 1 completed, 0 other |
| Linked publications | 5 (4 clinical trial publications, 1 Cochrane review) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | Open Targets, ChEMBL |
| Linked via biomarker / target | ADORA1 |
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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT01179828 | Linking Altered Central Pain Processing and Genetic Polymorphism to Drug Efficacy in Chronic Low Back Pain (Predictio) 2010 | completed | Phase 3 | 150 |
Published literature
- Cochrane review Efficacy of antidepressants in the treatment of chronic nonspecific low back pain: a systematic review and meta-analysisLeão Nunes Filho MJ, Barreto ESR, Antunes Júnior CR et al. · Pain management · 2024 · PMID 39377458
- Clinical trial publication Effect of single-dose imipramine on chronic low-back and experimental pain. A randomized controlled trialSchliessbach J, Siegenthaler A, Bütikofer L et al. · PloS one · 2018 · PMID 29742109
- Clinical trial publication Predicting drug efficacy in chronic low back pain by quantitative sensory testsSchliessbach J, Siegenthaler A, Bütikofer L et al. · European journal of pain (London, England) · 2018 · PMID 29363217
- Clinical trial publication Linking altered central pain processing and genetic polymorphism to drug efficacy in chronic low back painSiegenthaler A, Schliessbach J, Vuilleumier PH et al. · BMC pharmacology & toxicology · 2015 · PMID 26376691
- Clinical trial publication Controlled trial of imipramine for chronic low back painAlcoff J, Jones E, Rust P et al. · The Journal of family practice · 1982 · PMID 6210751
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 Open Targets and ChEMBL, in this case via the biomarker or target ADORA1. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Imipramine approved for Low Back Pain?
Imipramine has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Low Back Pain would be drug repurposing rather than first-in-human development. This does not mean it is approved for Low Back Pain. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Imipramine in clinical trials for Low Back Pain?
ClinicalTrials.gov lists 1 registered trial linking Imipramine to Low Back Pain: 1 has completed. The most advanced is Phase 3 (NCT01179828). It plans or enrolled 150 participants. Registered activity dates to 2010.
What does the evidence show for Imipramine in Low Back Pain?
Imipramine has both completed registered trials and synthesis-level publications linked to Low Back Pain. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL, in this case via the biomarker or target ADORA1. 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.