Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LHW090 · 3 trials · 3 indications
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. For LHW090, incidence of AEs by primary organ class presented
The area under the plasma concentration-time curve from time zero to 24 hours. Area Under the Curve (AUC0-t) after 4 days dosing will be reported for PART 1. LHW090 and LHV527 (its active metabolite)
Patients who developed a renal event will be reported (defined as a ≥0.3 mg/dL increase in serum creatinine from baseline within 24-48 hours post dose )
Number of participants with AEs, SAEs and deaths were assessed.
Change in the 12 hour average of systolic blood pressure (SBP) measured by ambulatory blood pressure was defined as the 12 hour daytime average SBP on Day 28 minus the 12 hour daytime average SBP on Day -1. monitoring (ABPM). A negative change from baseline indicates improvement.
In this analysis AE and SAE will be reported
In this analysis AE and SAE will be reported
In this analysis AE and SAE will be reported
| Arm | Type | Description |
|---|---|---|
| LHW090 | EXPERIMENTAL | For Part 1, patients will receive 3 doses of LHW090 once daily with escalating doses every 4 days for a total 12 days of treatment. For Part 2, patients will receive LHW090 once daily for 4 weeks. |
| Placebo | PLACEBO_COMPARATOR | For Part 1, patients will receive matching placebo once daily for 12 days. For Part 2, patients will receive matching placebo once daily for 4 weeks. |
| LHW090 100 mg | EXPERIMENTAL | LHW090 100 mg once daily for 28 days |
| LHW090 200 mg | EXPERIMENTAL | LHW090 200 mg once daily for 28 days |
| Stage 1 : LHW090, Healthy Volunteers | EXPERIMENTAL | Healthy Volunteers will receive single dose of LHW090 on Day 1. |
| Stage 2: LHW090, Healthy Volunteer | EXPERIMENTAL | Healthy Volunteers across 7 single ascending dose cohorts will be administered LHW090 or matching placebo day 1 |
| Stage 3: LHW090, Healthy Volunteer | EXPERIMENTAL | Healthy Volunteers across 6 multiple ascending dose cohorts will be administered LHW090 or matching placebo for 14 days. |
| Stage 4: LHW090, Patients | EXPERIMENTAL | Subjects with Chronic Renal Insufficiency across 3 cohorts will be administered a single dose of LHW090 in Day 1. |
| Name | Type | Description |
|---|---|---|
| LHW090 | DRUG | LHW090 is orally administered |
| Placebo | DRUG | Matching placebo of LHW090 |
Inclusion Criteria (all Parts): * Written informed consent must be obtained before any assessment is performed. * Male and female patients, age 40 to 85 years of age (inclusive) on a stable (at least 1 month) dose of an angiotensin receptor blocker (ARB) and stable moderately impaired renal functio...
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LHW090 is an investigational small molecule being studied for chronic kidney disease (CKD), resistant hypertension, and chronic renal insufficiency. It is being developed by Novartis AG (NVS) and is currently in clinical development, though it has not been approved by the FDA.
LHW090 is a small molecule developed by Novartis AG (NVS). Its specific molecular target has not been disclosed in available information, so its mechanism of action is not publicly detailed.
LHW090 is being developed by Novartis AG, a global pharmaceutical company traded on the New York Stock Exchange under the ticker NVS. The drug is an investigational small molecule in clinical development for kidney-related conditions.
LHW090 is in Phase 2 clinical development for chronic kidney disease and resistant hypertension. It has completed Phase 1 and Phase 2 trials, but it remains investigational and has not received FDA approval.
LHW090 has completed three clinical trials: NCT01846468, a Phase 1 study in healthy volunteers and subjects with renal dysfunction; NCT02515331, a Phase 2 study in resistant hypertension patients; and NCT02678000, a Phase 2 study in patients with moderately impaired renal function.
LHW090 is the sole name provided for this investigational drug. No alternative names or brand names have been disclosed in available information, so it is not known to be identical to any other marketed medication.