Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IW-1701 · 3 trials · 2 indications
An adverse event (AE) is any untoward medical occurrence that does not necessarily have to have a causal relationship with this treatment. A serious AE (SAE) is defined as any AE occurring at any dose that results in any of the following: death; life-threatening; hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; other important medical event. A TEAE is an event that occurs after initiation of randomized study drug through 28 days after study drug discontinuation. Events were categorized by grade: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death, and as related or unrelated to study drug. Adverse Events of special interest (AESIs) included symptomatic or Grade ≥2 hypotensive events and/or tachycardia AEs, bleeding events, pulmonary edema, and bone-related events, including fractures.
An AE is any untoward medical occurrence that does not necessarily have to have a causal relationship with this treatment. An SAE is defined as any AE occurring at any dose that results in any of the following: death; life-threatening; hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; other important medical event. A TEAE is an event that occurs after initiation of randomized study drug through 28 days after study drug discontinuation. Events were categorized by grade: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death, and as related or unrelated to study drug. If a participant had more than 1 occurrence in the same event category, only the occurrence with closest relationship to study drug was counted.
An AE is any untoward medical occurrence that does not necessarily have to have a causal relationship with this treatment. An SAE is defined as any AE occurring at any dose that results in any of the following: death; life-threatening; hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; other important medical event. A TEAE is an event that occurs after initiation of randomized study drug through 28 days after study drug discontinuation. Events were categorized by grade: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death, and as related or unrelated to study drug. If a participant had more than 1 occurrence in the same event category, only the most severe occurrence was counted.
An AE is any untoward medical occurrence that does not necessarily have to have a causal relationship with this treatment. An SAE is defined as any AE occurring at any dose that results in any of the following: death; life-threatening; hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; other important medical event. A TEAE is an event that occurs after initiation of randomized study drug through 28 days after study drug discontinuation. Events were categorized by grade: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death, and as related or unrelated to study drug. If a participant had more than 1 occurrence in the same event category, only the occurrence with closest relationship to study drug was counted.
Maximum observed Plasma Concentration
Area under the plasma concentration time curve during a dosing interval
Time of maximum observed plasma concentration
The primary objectives of this study are to assess the safety and tolerability of single ascending dosage levels of IW-1701 versus placebo in healthy subjects.
| Arm | Type | Description |
|---|---|---|
| IW-1701 (Olinciguat) 2 mg | EXPERIMENTAL | After a single-blind treatment with placebo once daily (QD) for 14 to 17 days of the Screening period and before the first dose of double-blind study drug on Day 1, participants received 1 mg olinciguat QD Week 1 and 2 mg olinciguat QD Weeks 2-12 under the original protocol, Amendment 1, Amendment 2, and Amendment 3. |
| IW-1701 (Olinciguat) 4 mg | EXPERIMENTAL | After a single-blind treatment with placebo QD for 14 to 17 days of the Screening period and before the first dose of double-blind study drug on Day 1, participants received 2 mg olinciguat QD Week 1 and 4 mg olinciguat QD Weeks 2-12 under the original protocol, Amendment 1, Amendment 2, and Amendment 3. |
| IW-1701 (Olinciguat) 6 mg | EXPERIMENTAL | After a single-blind treatment with placebo QD for 14 to 17 days of the Screening period and before the first dose of double-blind study drug on Day 1, participants received 3 mg olinciguat QD Week 1 and 6 mg olinciguat QD Weeks 2-12 under the original protocol, Amendment 1, Amendment 2, and Amendment 3. |
| IW-1701 (Olinciguat) 18 mg | EXPERIMENTAL | After a single-blind treatment with placebo QD for 14 to 17 days of the Screening period and before the first dose of double-blind study drug on Day 1, participants received 6 mg olinciguat QD Days 1-7, 12 mg olinciguat QD Weeks 1-3, and 18 mg olinciguat QD Weeks 4-12 under protocol Amendment 4 and later. |
| Placebo | PLACEBO_COMPARATOR | After a single-blind treatment with placebo QD for 14 to 17 days of the Screening period and before the first dose of double-blind study drug on Day 1, participants received placebo treatment QD for 12 weeks. |
| IW-1701 | EXPERIMENTAL | IW-1701 tablets administered orally in multiple ascending dose. |
| Matching Placebo for IW-1701 | PLACEBO_COMPARATOR | Single Dose |
| Name | Type | Description |
|---|---|---|
| IW-1701 | DRUG | Oral Tablet |
| Placebo | DRUG | Oral Tablet |
| Matching Placebo | DRUG | - |
INCLUSION CRITERIA 1. Patient is ambulatory male or female 16 to 70 years of age at the Screening Visit. 2. Patient has SCD, including homozygous hemoglobin S (HbSS), hemoglobin SC disease (HbSC), heterozygous hemoglobin S-beta zero (HbSβ0)-thalassemia, or heterozygous hemoglobin S-beta plus (HbSβ+...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novo Nordisk A/S Sponsored ADR Class B | NVO | 5 | PHASE3 | Etavopivat Low dose |
| Novartis AG Sponsored ADR | NVS | 4 | PHASE3 | Crizanlizumab |
| Sanofi SA Sponsored ADR | SNY | 2 | PHASE3 | PCV21, 20vPCV |
| Vertex Pharmaceuticals Incorporated | VRTX | 3 | PHASE3 | CTX001 |
| Agios Pharmaceuticals, Inc. | AGIO | 2 | PHASE2 | Mitapivat |
| Pfizer Inc. | PFE | 1 | PHASE2 | Osivelotor |
| Bristol-Myers Squibb Company | BMY | 1 | PHASE1 | BMS-986470, Famotidine, Pantoprazole |
| Fulcrum Therapeutics, Inc. | FULC | 1 | PHASE2 | Pociredir |
| Beam Therapeutics, Inc. | BEAM | 2 | PHASE1 | BEAM-101 |
| Editas Medicine, Inc. | EDIT | 2 | PHASE1 | EDIT-301 |
| Disc Medicine, Inc. | IRON | 1 | PHASE1 | DISC-3405 |
| Illumina, Inc. | ILMN | 1 | - | Undisclosed |
IW-1701, also known as olinciguat, is an investigational small molecule being studied for use in sickle cell disease. It has been evaluated in clinical trials involving patients with sickle cell disease as well as in healthy volunteers. The drug is not approved and remains in clinical development.
IW-1701 targets soluble guanylate cyclase (sGC), an enzyme involved in cellular signaling. As a stimulator of sGC, it is being investigated for its potential effects in conditions like sickle cell disease. This mechanism was the focus of its early clinical trials in healthy subjects.
IW-1701 is being developed by Cyclerion Therapeutics, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol CYCN. Cyclerion has conducted clinical trials of IW-1701 in the United States and other countries.
IW-1701 has completed Phase 1 and Phase 2 clinical trials. Two Phase 1 trials in healthy volunteers and one Phase 2 trial in patients with sickle cell disease have been completed. The drug is investigational and has not received FDA approval.
IW-1701 has been studied in three completed clinical trials. These include NCT02572349 and NCT02792998, both Phase 1 trials in healthy volunteers, and NCT03285178, a Phase 2 trial in patients with sickle cell disease. All trials have been completed.
Yes, IW-1701 is also known as olinciguat. The Phase 2 trial in sickle cell disease refers to the drug as olinciguat, while earlier trials used the name IW-1701. Both names refer to the same investigational small molecule developed by Cyclerion Therapeutics.