Dapansutrile (Olatec, OLT1177) — Investigational, Not Yet Approved
Pronunciation: dap-AN-soo-trile.
- Generic name
- dapansutrile
- Drug class
- Investigational oral selective NLRP3 inflammasome inhibitor
- Form
- Not established — no approved dosage form exists
- Route
- Oral (investigational)
- Legal status
- Investigational only. Not approved by the FDA or any other national regulator. The reviewed sources describe access only through clinical research participation; broader legal availability status was not independently established.
Availability and supply rules vary by country
Trade names by country:
Australia: · Full directory
What dapansutrile is and how it works
Dapansutrile (development code OLT1177) is an investigational oral small molecule developed by Olatec Therapeutics that selectively inhibits the NLRP3 inflammasome, a component of the innate immune system involved in inflammatory diseases. It works upstream of interleukin-1 beta (IL-1β), an inflammatory signaling protein, by blocking activation of the NLRP3 inflammasome pathway. (1) (2)
Dapansutrile is NOT an approved medicine. No regulatory authority — not the FDA, EMA, MHRA, TGA, or Health Canada — has approved it for any use. The reviewed sources describe access to it only through clinical research participation. This page exists to track its investigational development status honestly, including the speculative possibility of approval in 2026-2027 if a Phase 2/3 trial in acute gout flares succeeds; the reviewed sources describe this trial as conducted or being conducted but do not conclusively confirm its current status. The 2026-2027 timeline is not confirmed by any source and must not be read as a scheduled or guaranteed event. If you are looking for treatment for gout or another condition, speak with a licensed clinician about currently approved options rather than seeking this investigational drug.
Mechanism of action: how dapansutrile works
Dapansutrile is a selective small-molecule inhibitor of the NLRP3 inflammasome, acting upstream of interleukin-1 beta (IL-1β) activation. Beyond this mechanism-level description from the reviewed Phase 2a publication, detailed pharmacokinetic data (absorption, metabolism, elimination) were not captured in the sources reviewed for this page. (1) (2)
What dapansutrile is used for
Investigational use in clinical trials only
Dapansutrile is being studied, not used clinically. A multi-center Phase 2/3 randomized, double-blind, placebo-controlled trial has been conducted or is being conducted in patients with an acute gout flare (current status not conclusively confirmed in the reviewed sources), building on an earlier open-label, dose-adaptive Phase 2a proof-of-concept trial that showed a reduction in target-joint pain across the dose groups studied. Separately, earlier-phase studies have investigated dapansutrile for osteoarthritis and cardiovascular-disease-related indications, and a Phase 1/2 investigator-initiated study has evaluated it combined with the checkpoint inhibitor pembrolizumab in PD-1-refractory advanced melanoma. None of these represent an approved indication; all are early-phase or not-yet-confirmed-status research only. (1) (2)
Before taking dapansutrile
Do not take / not appropriate for
- Dapansutrile is investigational and not an approved medicine. The reviewed sources describe access to it through clinical research participation; broader legal availability or prescription/purchase status was not independently established. If considering it, ask a licensed clinician about clinical trial enrollment rather than seeking it through another channel. (investigational status) (2)
Tell your clinician about
- If you are considering enrolling in a clinical trial of dapansutrile, discuss your full medical history, current medications, and the trial's specific eligibility criteria with the trial investigators before enrolling — the sources reviewed for this page did not establish any drug-interaction or contraindication data outside of a trial protocol.
How to take dapansutrile
- There is no approved dose, schedule, or administration instruction for dapansutrile, because it is not an approved medicine.
- Any dosing that exists is defined only within the protocol of a specific clinical trial and is set by that trial's investigators, not by a public prescribing label.
- Do not attempt to obtain or self-administer dapansutrile outside of a clinical trial setting; the reviewed sources describe access only through clinical research participation.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3)
Missed dose
Not applicable outside a clinical trial. Anyone enrolled in a dapansutrile trial who misses a scheduled dose should follow that trial's specific protocol and contact the trial investigators directly, rather than relying on general public missed-dose guidance, because none exists for this investigational drug.
Overdose
Whether an overdose-management protocol exists for dapansutrile was not established in the sources reviewed for this page; this remains unresolved rather than confirmed. Anyone enrolled in a dapansutrile clinical trial who is concerned about a possible overdose should contact the trial investigators or seek emergency medical care immediately and inform the treating clinicians that they are participating in an investigational drug trial.
Side effects
Because dapansutrile has not completed a pivotal trial or regulatory review, there is no publicly available, comprehensive side-effect profile for it of the kind normally published on an approved medicine's label. The points below describe what is and is not known from the early-phase research reviewed for this page.
Comprehensive adverse-event profile not yet established
What to notice: Not applicable — no publicly available list of common or expected side effects exists for dapansutrile from a completed pivotal trial.
What to do: Do not assume dapansutrile is safe or well tolerated based on early-phase efficacy signals alone. Anyone in a trial experiencing any new or concerning symptom should contact the trial investigators promptly. (1)
Phase 2a gout trial reported an efficacy signal, not a full safety dataset
What to notice: The published Phase 2a proof-of-concept trial in acute gout flares reported reduced target-joint pain across dose groups; it was an early-phase, open-label, dose-adaptive study, which is not designed to establish a definitive side-effect or safety profile.
What to do: Treat any safety impression from this early-phase data as preliminary. A full accounting of adverse events has not been established in the sources reviewed for this page. (1)
Any new or concerning symptom while enrolled in a dapansutrile clinical trial
What to notice: Not established in the sources reviewed for this page — no specific investigational-drug adverse-event list is publicly available.
What to do: Contact the trial investigators promptly, or seek emergency medical care if symptoms are severe, and inform any treating clinician that you are taking an investigational drug in a clinical trial. (2)
Serious warnings
Investigational status — not an approved medicine — critical safety context
Symptoms: Not applicable.
Action: Dapansutrile has not been approved by the FDA or any other regulator for any use. The reviewed sources describe access to it only through clinical research participation; broader legal availability or purchase status was not independently established. Anyone interested in dapansutrile should ask a licensed clinician about clinical trial enrollment rather than seeking the drug through any other channel. (2) (3)
Interactions
| Medicine or test | Effect | Action |
|---|---|---|
| All other medications and supplements | No drug-interaction data have been established for dapansutrile in the sources reviewed for this page, because it has not completed the trials or regulatory review that would generate that data. | Anyone enrolled in a dapansutrile clinical trial should disclose all other medications and supplements to the trial investigators and follow the trial protocol precisely, rather than relying on any general interaction guidance, because none exists publicly for this drug. (2) |
Pregnancy, breastfeeding, kidney/liver function, age
Pregnancy and breastfeeding
No pregnancy or lactation safety data for dapansutrile were identified in the sources reviewed for this page. This remains unresolved.
Children
No pediatric trial data for dapansutrile were identified in the sources reviewed for this page. This is unresolved.
Monitoring
Before starting
- Confirm eligibility for a specific clinical trial with the trial investigators; there is no public prescribing pathway for dapansutrile outside of a trial.
During treatment
- Anyone enrolled in a dapansutrile trial should follow that trial's specific monitoring schedule and report any new symptom to the trial investigators promptly.
Storage
No public storage instructions exist for dapansutrile, because it is not an approved, commercially available product. Anyone enrolled in a clinical trial should follow the storage instructions provided by the trial site.
Professional information
Dapansutrile (OLT1177) is an investigational drug with no approved prescribing label anywhere. It has not been reviewed or authorised by the FDA, EMA, MHRA, TGA, or Health Canada. The information below reflects only what is publicly documented from early-phase clinical research and company trial listings, and must not be read as prescribing guidance.
All regions
Indication: None — investigational only, no approved indication anywhere
Dose summary: No approved dose exists. Dosing used in ongoing trials is set by each trial's protocol and has not been published as a general prescribing recommendation in the sources reviewed for this page.
Renal context: No renal-impairment dosing data have been established for dapansutrile in the sources reviewed for this page; this remains unresolved. (2)
Hepatic guidance
No hepatic-impairment data for dapansutrile were identified in the sources reviewed for this page; this remains unresolved.
Overdose note
Whether an overdose-management protocol exists for dapansutrile was not established in the sources reviewed for this page; this remains unresolved. (1) (2)
Frequently asked questions
Is dapansutrile (Olatec) FDA-approved?
No. As of the sources reviewed for this page, dapansutrile has not been approved by the FDA or any other national regulator. It remains an investigational drug in clinical trials. (2) (3)
What is dapansutrile being studied for?
It is being studied primarily for acute gout flares in a Phase 2/3 trial that has been conducted or is being conducted (current status not conclusively confirmed in the reviewed sources), building on an earlier Phase 2a proof-of-concept study. It has also been studied in earlier-phase settings for osteoarthritis, cardiovascular-disease-related indications, and — in combination with pembrolizumab — advanced melanoma. (1) (2)
Will dapansutrile be approved in 2026 or 2027?
This is not established or confirmed by any source reviewed for this page. Approval in that window is possible only if the Phase 2/3 trial succeeds and a subsequent regulatory review is completed; no specific date, filing, or approval probability has been published. (2) (3)
Can I get dapansutrile outside of a clinical trial?
The reviewed sources describe access to dapansutrile only through clinical research participation; broader legal availability status was not independently established. Ask a licensed clinician about enrolling in an active trial if you are interested, rather than seeking it through any other source. (2)
What is the mechanism of action of dapansutrile?
Dapansutrile is a selective small-molecule inhibitor of the NLRP3 inflammasome, acting upstream of interleukin-1 beta (IL-1β) activation. Beyond this mechanism-level description from the reviewed Phase 2a publication, detailed pharmacokinetic data (absorption, metabolism, elimination) were not captured in the sources reviewed for this page. (1) (2)
What is the generic name of Dapansutrile (Olatec, OLT1177) — Investigational, Not Yet Approved?
References
- Dapansutrile, an oral selective NLRP3 inflammasome inhibitor, for treatment of gout flares: an open-label, dose-adaptive, proof-of-concept, phase 2a trialScienceDirect / PubMed · Global · dated 2020 · accessed 2026-08-05 · source 1
- Company pipeline and clinical trialsOlatec Therapeutics · United States · accessed 2026-08-05 · source 2
- Dapansutrile drug development pipelineDrugPatentWatch · Global · accessed 2026-08-05 · source 3
Brand names by country
Single-ingredient dapansutrile names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.