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SCP-111

Phase 1

Heart Failure | Small molecule | Cardiovascular |MannKind Corporation|Last Updated: Mar 30, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment21

FDA Designations

No designations recorded

Clinical trial landscape

SCP-111 · 1 trial · 2 indications

Phase 1 1
NCT06167707Pharmacokinetics and Pharmacodynamics of Subcutaneous vs Intravenous Furosemide in Healthy VolunteersHeart Failure
COMPLETED21 Analytics
PHASE1COMPLETED
Pharmacokinetics and Pharmacodynamics of Subcutaneous vs Intravenous Furosemide in Healthy Volunteers
Heart FailureUnlock trial analytics

Study Endpoints

Primary Endpoints

AUClast
SC SCP-111: 0, 5, 15, 30, 45 minutes and 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose. IV Furosemide: 0, 5, 15, 30, 45 minutes and 1, 1.5, 2 hours after 1st IV dose; 5, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 hours after 2nd IV dose. IV:

Area under the plasma concentration-time curve from time 0 (pre-dose) to time of last measurable plasma concentration.

AUCinf
SC SCP-111: 0, 5, 15, 30, 45 minutes and 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose. IV Furosemide: 0, 5, 15, 30, 45 minutes and 1, 1.5, 2 hours after 1st IV dose; 5, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 hours after 2nd IV dose.

Area under the plasma concentration-time curve from time 0 (pre-dose) extrapolated to infinity.

AUCext
SC SCP-111: 0, 5, 15, 30, 45 minutes and 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose. IV Furosemide: 0, 5, 15, 30, 45 minutes and 1, 1.5, 2 hours after 1st IV dose; 5, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 hours after 2nd IV dose.

The percentage of the AUC that is extrapolated beyond the last measurable concentration.

Cmax
SC SCP-111: 0, 5, 15, 30, 45 minutes and 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose. IV Furosemide: 0, 5, 15, 30, 45 minutes and 1, 1.5, 2 hours after 1st IV dose; 5, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 hours after 2nd IV dose.

Maximum observed plasma concentration of Furosemide

Tmax
SC SCP-111: 0, 5, 15, 30, 45 minutes and 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose. IV Furosemide: 0, 5, 15, 30, 45 minutes and 1, 1.5, 2 hours after 1st IV dose; 5, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 hours after 2nd IV dose.

Time of maximum observed Furosemide plasma concentration

λz
SC SCP-111: 0, 5, 15, 30, 45 minutes and 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose. IV Furosemide: 0, 5, 15, 30, 45 minutes and 1, 1.5, 2 hours after 1st IV dose; 5, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 hours after 2nd IV dose.

Apparent plasma terminal-phase elimination rate constant

SC SCP-111: 0, 5, 15, 30, 45 minutes and 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose. IV Furosemide: 0, 5, 15, 30, 45 minutes and 1, 1.5, 2 hours after 1st IV dose; 5, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 hours after 2nd IV dose.

Terminal-phase half-life

Clearance
SC SCP-111: 0, 5, 15, 30, 45 minutes and 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose. IV Furosemide: 0, 5, 15, 30, 45 minutes and 1, 1.5, 2 hours after 1st IV dose; 5, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 hours after 2nd IV dose.

Systemic clearance for IV furosemide (CL) and Apparent systemic clearance for SC furosemide (CL/F)

Volume of Distribution, Terminal Phase
SC SCP-111: 0, 5, 15, 30, 45 minutes and 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose. IV Furosemide: 0, 5, 15, 30, 45 minutes and 1, 1.5, 2 hours after 1st IV dose; 5, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 hours after 2nd IV dose.

Systemic Volume of distribution, terminal phase for IV furosemide (V) and Apparent Volume of distribution, terminal phase for SC furosemide (Vz/F)

Urine Output 0-6 Hours
0-1, 1-2, 2-3, 3-4, 4-5, 5-6 hours post-dose

Total Urine Output from 0 to 6 hours

Urine Output 0-8 Hours
0-1, 1-2, 2-3, 3-4, 4-5, 5-6, 6-7, 7-8 hours post-dose

Total Urine Output from 0 to 8 hours

Urine Output 0-12 Hours
0-1, 1-2, 2-3, 3-4, 4-5, 5-6, 6-7, 7-8, 8-10, 10-12 hours post-dose

Total Urine Output from 0 to 12 hours

Urinary Sodium 0-6 Hours
0-1, 1-2, 2-3, 3-4, 4-5, 5-6 hours post-dose

Urinary sodium excretion from 0 to 6 hours

Urinary Sodium 0-8 Hours
0-1, 1-2, 2-3, 3-4, 4-5, 5-6, 6-7, 7-8 hours post-dose

Urinary sodium excretion from 0 to 8 hours

Urinary Sodium 0-12 Hours
0-1, 1-2, 2-3, 3-4, 4-5, 5-6, 6-7, 7-8, 8-10, 10-12 hours post-dose

Urinary sodium excretion from 0 to 12 hours

Urinary Potassium 0-6 Hours
0-1, 1-2, 2-3, 3-4, 4-5, 5-6 hours post-dose

Urinary potassium excretion from 0 to 6 hours

Urinary Potassium 0-8 Hours
0-1, 1-2, 2-3, 3-4, 4-5, 5-6, 6-7, 7-8 hours post-dose

Urinary potassium excretion from 0 to 8 hours

Urinary Potassium 0-12 Hours
0-1, 1-2, 2-3, 3-4, 4-5, 5-6, 6-7, 7-8, 8-10, 10-12 hours post-dose

Urinary potassium excretion from 0 to 12 hours

Secondary Endpoints

Injection Site Pain
SC SCP-111: pre-dose, immediately after dose, 15, 30 minutes and 6,12 hours post-dose. IV Furosemide: pre-dose, after place IV needle, immediately after 1st IV dose; 15, 30, minutes, immediately after 2nd dose,15, 30 minutes and 4, 10 hours after 2nd dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Treatment Sequence 1EXPERIMENTALPeriod 1: SC Period 2: IV
Treatment Sequence 2EXPERIMENTALPeriod 1: IV Period 2: SC

Interventions

NameTypeDescription
SCP-111DRUGFurosemide injection 80 mg/mL, 80 mg SC via autoinjector x 1 dose
Furosemide USPDRUGFurosemide injection, USP 10 mg/mL, 40 mg IV over 2 minutes followed by 40 mg 2 hours later
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Eligibility Criteria

Age Range45 Years to 80 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. An Institutional Review Board (IRB) approved informed consent is signed and dated prior to any study-related activities. 2. Male and female subjects 45 to 80 years of age. 3. Has the ability to understand the requirements of the study and is willing to comply with all study p...

Countries:United States
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Frequently asked questions about SCP-111

What is SCP-111 used for?

SCP-111 is an investigational small molecule being developed for heart failure, specifically to address fluid overload. It is a cardiovascular therapeutic candidate studied in a Phase 1 clinical trial. The drug is not yet approved and remains in clinical development.

How does SCP-111 work?

SCP-111 is a small molecule intended for heart failure with fluid overload. Its mechanism involves pharmacokinetic and pharmacodynamic effects similar to furosemide, a loop diuretic, as evaluated in a clinical trial comparing subcutaneous and intravenous administration. The specific molecular target has not been disclosed.

Who makes SCP-111?

SCP-111 is being developed by MannKind Corporation, a biopharmaceutical company listed on NASDAQ under the ticker MNKD. The company is conducting clinical research on this investigational cardiovascular drug candidate.

What phase is SCP-111 in?

SCP-111 is in Phase 1 clinical development. A Phase 1 trial has been completed, evaluating the drug in healthy volunteers. SCP-111 is investigational and has not received FDA approval.

What clinical trials is SCP-111 in?

SCP-111 has one completed Phase 1 clinical trial, NCT06167707, titled 'Pharmacokinetics and Pharmacodynamics of Subcutaneous vs Intravenous Furosemide in Healthy Volunteers.' The trial enrolled 21 participants in the United States, with healthy volunteers aged 45 years and older.

Is SCP-111 the same as furosemide?

SCP-111 is being studied in a trial that compares subcutaneous and intravenous furosemide, but SCP-111 itself is a distinct investigational drug candidate. The trial evaluates the pharmacokinetics and pharmacodynamics of these administration routes in healthy volunteers, and SCP-111 is not listed as an alternative name for furosemide.