Summary
Imipramine has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Fibromyalgia would be drug repurposing rather than first-in-human development. This does not mean it is approved for Fibromyalgia. ClinicalTrials.gov lists 1 registered trial linking Imipramine to Fibromyalgia: 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 245 participants. Registered activity dates to 2021. The literature layer holds 1 publication for this pair: 1 meta-analysis. The dated items are from 2002. 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 Fibromyalgia ranks 50 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: Partial spontaneous improvement in ~25-30% over 5 years; complete resolution without treatment rare; chronic fluctuating course in majority; central sensitisation often persists.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 27.0 (trials 3.0, literature 4.0, 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 meta-analysis) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | Open Targets, ChEMBL |
| Linked via biomarker / target | ACHE |
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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT04832100 | Bio-significance of LPC16:0 in Fibromyalgia 2021 | recruiting | Not applicable | 245 |
Published literature
- Meta-analysis Are antidepressants effective in fibromyalgia?Thomas E, Blotman F · Joint bone spine · 2002 · PMID 12537258
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 ACHE. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Imipramine approved for Fibromyalgia?
Imipramine has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Fibromyalgia would be drug repurposing rather than first-in-human development. This does not mean it is approved for Fibromyalgia. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Imipramine in clinical trials for Fibromyalgia?
ClinicalTrials.gov lists 1 registered trial linking Imipramine to Fibromyalgia: 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 245 participants. Registered activity dates to 2021.
What does the evidence show for Imipramine in Fibromyalgia?
Trials of Imipramine in Fibromyalgia 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 Open Targets and ChEMBL, in this case via the biomarker or target ACHE. 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 2026-07-06. Page built 2026-10-07.