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LiRIS low dose and LiRIS high dose · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| LiRIS low dose | EXPERIMENTAL | The first dose group of approximately 10 patients receive low dose LiRIS on Day 1 to Day 14. |
| LiRIS high dose | EXPERIMENTAL | The second dose group of approximately 10 patients receive high dose LiRIS on Day 1 to Day 14. |
| Name | Type | Description |
|---|---|---|
| LiRIS low dose and LiRIS high dose | DRUG | Drug delivery system containing lidocaine; LiRIS (low or high dose) is inserted into bladder via cystoscopy on Day 1 and removed via cystoscopy on Day 14. Designed to release lidocaine over a 14 day period. |
Inclusion Criteria: * Female patients ≥ 18 years of age * If of child-bearing potential, agrees to use effective contraception defined by protocol * Capable of understanding and completing symptom diaries and questionnaires as required in the study * Diagnosed with IC, as defined by protocol criter...
LiRIS is an investigational small molecule being developed for interstitial cystitis, also known as bladder pain syndrome. It has been studied in women with interstitial cystitis, including those with Hunner's lesions, which are ulcerations in the bladder wall. The drug is delivered locally to the bladder to treat this chronic condition.
LiRIS is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The drug is in clinical development for interstitial cystitis, a chronic bladder condition. AbbVie has sponsored multiple clinical trials evaluating LiRIS in female patients.
LiRIS is an investigational drug that has completed Phase 1 and Phase 2 clinical trials. It is not approved by the FDA and remains in clinical development. The completed trials evaluated safety, tolerability, and preliminary efficacy in women with interstitial cystitis, including those with Hunner's lesions.
LiRIS has been studied in four completed clinical trials. These include NCT01150565 and NCT01879683, which were Phase 1 safety studies in women with interstitial cystitis. Two Phase 2 trials, NCT02395042 and NCT02411110, evaluated safety and efficacy in women with interstitial cystitis, including those with Hunner's lesions and bladder pain syndrome.
LiRIS is designed for local delivery to the bladder. Clinical trials enrolled women aged 18 years and older with interstitial cystitis. The studies were conducted in the United States and Canada. The drug was evaluated as a treatment for interstitial cystitis, including cases with Hunner's lesions.
LiRIS is a distinct investigational small molecule developed specifically for interstitial cystitis. It has been studied in women with this condition, including those with Hunner's lesions. No alternative names for LiRIS have been reported in clinical trial records.