Recent Updates
Recently added Catalysts

Technosphere

Phase 1

Mild Nephropathy | Small molecule | Metabolic |MannKind Corporation|Last Updated: Dec 17, 2013

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment36
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00626249Single Dose, Single Administration Study of Technosphere Inhalation Powder in Diabetic Subjects With Mild or Moderate Kidney Disease Compared to Diabetic Subjects With Normal Kidney FunctionPHASE1 COMPLETED 36Aug 1, 2007Oct 1, 2008Dec 17, 20133 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Differences in exposure to fumaryl diketopiperazine (FDKP)
14 days
Secondary Endpoints
Additional safety parameters
14 days
Unlock Study Endpoints
Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
T Inhalation powder in diabetic subjs w/ normal renal funcEXPERIMENTALT inhalation powder in diabetic subjects with normal renal function, Single dose, 30 units
T Inhalation powder diabetic subj w/mild or moderate nephropEXPERIMENTALT Inhalation powder in diabetic subjects w/mild or moderate nephropathy - Single dose, 30 units
Interventions
NameTypeDescription
Technosphere Inhalation PowderDRUGTechnosphere Inhalation Powder
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Non-smoking males and females, = 18 and = 80 years with a BMI of = 37 kg/m2 * Type 1 or type 2 diabetic * Subjects with mild or moderate DNP and subjects with normal renal function, based on GFR rate and albuminuria * Normal pulmonary function and performance based on PFTs Ex...

Countries:United States
Unlock Eligibility Criteria
Competitive Landscape -Diabetic Nephropathy 8 trials