Summary
Imipramine has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in GERD (Gastroesophageal Reflux Disease) would be drug repurposing rather than first-in-human development. This does not mean it is approved for GERD (Gastroesophageal Reflux Disease). ClinicalTrials.gov lists 2 registered trials linking Imipramine to GERD (Gastroesophageal Reflux Disease): 1 is currently recruiting; 1 has completed. The most advanced is Phase 3 (NCT01753128). The largest enrolment is 610 participants (NCT06778824). Registration activity spans 2012 to 2024. The literature layer holds 2 publications for this pair: 1 Cochrane review and 1 clinical trial publication. Publication years run from 2014 to 2016. 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 Gastroesophageal Reflux Disease ranks 203 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: Symptom recurrence in 70-80% within 6 months of PPI discontinuation in erosive GERD; highly variable in non-erosive disease; ~20% of GERD is nonerosive, where acid suppression is less effective.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 34.5 (trials 7.5, literature 7.0, tier 15, approved bonus 5.0) |
| Registered trials | 2 total: 1 recruiting, 0 active / not yet recruiting, 1 completed, 0 other |
| Linked publications | 2 (1 Cochrane review, 1 clinical trial publication) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | Open Targets, ChEMBL |
| Linked via biomarker / target | ABCC8 |
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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT01753128 | Efficacy of Imipramine for Treatment of Patients With Esophageal Hypersensitivity/ Functional Heartburn 2012 | completed | Phase 3 | 83 |
| NCT06778824 | Neuroregulators for the Treatment of Diseases Associated With Esophageal-brain-gut Axis Communication Abnormalities. 2024 | recruiting | Not applicable | 610 |
Published literature
- Clinical trial publication Imipramine for Treatment of Esophageal Hypersensitivity and Functional Heartburn: A Randomized Placebo-Controlled TrialLimsrivilai J, Charatcharoenwitthaya P, Pausawasdi N et al. · The American journal of gastroenterology · 2016 · PMID 26753892
- Cochrane review Treatment of esophageal (noncardiac) chest pain: an expert reviewCoss-Adame E, Erdogan A, Rao SS · Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2014 · PMID 23994670
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 ABCC8. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Imipramine approved for GERD (Gastroesophageal Reflux Disease)?
Imipramine has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in GERD (Gastroesophageal Reflux Disease) would be drug repurposing rather than first-in-human development. This does not mean it is approved for GERD (Gastroesophageal Reflux Disease). Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Imipramine in clinical trials for GERD (Gastroesophageal Reflux Disease)?
ClinicalTrials.gov lists 2 registered trials linking Imipramine to GERD (Gastroesophageal Reflux Disease): 1 is currently recruiting; 1 has completed. The most advanced is Phase 3 (NCT01753128). The largest enrolment is 610 participants (NCT06778824). Registration activity spans 2012 to 2024.
What does the evidence show for Imipramine in GERD (Gastroesophageal Reflux Disease)?
Imipramine has both completed registered trials and synthesis-level publications linked to GERD (Gastroesophageal Reflux Disease). 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 ABCC8. 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.