Adults 16 to 70, any sex, with Sickle Cell Disease. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Double-Blind Treatment: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)Primary· First dose of randomized drug through 28 days after study drug discontinuation. Median number of weeks of treatment was 12.30, 11.85, 12.20, 12.20, 12.10, and 12.10, respectively, for Placebo 1, Placebo 2, Olinciguat 2 mg, 4 mg, 6 mg, and 18 mg groups.
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=mil
Double-Blind Treatment: Number of TEAE EventsPrimary· First dose of randomized drug through 28 days after study drug discontinuation. Median number of weeks of treatment was 12.30, 11.85, 12.20, 12.20, 12.10, and 12.10, respectively, for Placebo 1, Placebo 2, Olinciguat 2 mg, 4 mg, 6 mg, and 18 mg groups.
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=l
Group
Value
95% CI
Placebo 1
26
Placebo 2
29
IW-1701 (Olinciguat) 2 mg
36
IW-1701 (Olinciguat) 4 mg
30
IW-1701 (Olinciguat) 6 mg
39
IW-1701 (Olinciguat) 18 mg
101
Double-Blind Treatment: Number of Participants With ≥1 TEAE, by Maximum SeverityPrimary· First dose of randomized drug through 28 days after study drug discontinuation. Median number of weeks of treatment was 12.30, 11.85, 12.20, 12.20, 12.10, and 12.10, respectively, for Placebo 1, Placebo 2, Olinciguat 2 mg, 4 mg, 6 mg, and 18 mg groups.
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=l
Participants with ≥1 TEAE: Any
Group
Value
95% CI
Placebo 1
6
Placebo 2
6
IW-1701 (Olinciguat) 2 mg
5
IW-1701 (Olinciguat) 4 mg
5
IW-1701 (Olinciguat) 6 mg
8
IW-1701 (Olinciguat) 18 mg
21
Participants with ≥1 TEAE: Grade 1
Group
Value
95% CI
Placebo 1
0
Placebo 2
4
IW-1701 (Olinciguat) 2 mg
0
IW-1701 (Olinciguat) 4 mg
2
IW-1701 (Olinciguat) 6 mg
2
IW-1701 (Olinciguat) 18 mg
6
Participants with ≥1 TEAE: Grade 2
Group
Value
95% CI
Placebo 1
4
Placebo 2
0
IW-1701 (Olinciguat) 2 mg
3
IW-1701 (Olinciguat) 4 mg
0
IW-1701 (Olinciguat) 6 mg
2
IW-1701 (Olinciguat) 18 mg
8
Participants with ≥1 TEAE: Grade 3
Group
Value
95% CI
Placebo 1
2
Placebo 2
2
IW-1701 (Olinciguat) 2 mg
2
IW-1701 (Olinciguat) 4 mg
3
IW-1701 (Olinciguat) 6 mg
4
IW-1701 (Olinciguat) 18 mg
7
Participants with ≥1 TEAE: Grade 4
Group
Value
95% CI
Placebo 1
0
Placebo 2
0
IW-1701 (Olinciguat) 2 mg
0
IW-1701 (Olinciguat) 4 mg
0
IW-1701 (Olinciguat) 6 mg
0
IW-1701 (Olinciguat) 18 mg
0
Participants with ≥1 TEAE: Grade 5
Group
Value
95% CI
Placebo 1
0
Placebo 2
0
IW-1701 (Olinciguat) 2 mg
0
IW-1701 (Olinciguat) 4 mg
0
IW-1701 (Olinciguat) 6 mg
0
IW-1701 (Olinciguat) 18 mg
0
Double-Blind Treatment: Number of Participants With Study Drug-Related TEAEsPrimary· First dose of randomized drug through 28 days after study drug discontinuation. Median number of weeks of treatment was 12.30, 11.85, 12.20, 12.20, 12.10, and 12.10, respectively, for Placebo 1, Placebo 2, Olinciguat 2 mg, 4 mg, 6 mg, and 18 mg groups.
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=l
Group
Value
95% CI
Placebo 1
3
Placebo 2
0
IW-1701 (Olinciguat) 2 mg
2
IW-1701 (Olinciguat) 4 mg
0
IW-1701 (Olinciguat) 6 mg
4
IW-1701 (Olinciguat) 18 mg
7
Adverse events — posted to ClinicalTrials.gov
Time frame: AEs during Single-blind Run-in Period were collected from first dose of Run-in placebo up to the first dose of randomized study drug, up to 17 days. AEs during the Double-Blind Period: First dose of randomized drug through 28 days after study drug discontinuation. Median number of weeks of treatment was 12.30, 11.85, 12.20, 12.20, 12.10, and 12.10, respectively, for Placebo 1, Placebo 2, Olinciguat 2 mg, 4 mg, 6 mg, and 18 mg groups..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The primary objective of the 1701-202 STRONG SCD study is to evaluate the safety and tolerability of different dose levels of IW-1701 compared with placebo when administered daily for approximately 12 weeks to patients with stable SCD. Exploratory objectives include evaluation of pharmacokinetic (PK) as well as evaluation of the effect of IW-1701 on symptoms of SCD, health-related quality of life, and biomarkers of pharmacodynamic (PD) activity.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Cyclerion Therapeutics
Last refreshed: 21 July 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03285178.