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RECORDATI

RECORDATI logo
🇮🇹Italy
Ownership
Private
Established
1926-01-01
Employees
501
Market Cap
$12B
Website
https://www.recordati.com.tr

Clinical Trials

17

Active:5
Completed:9

Trial Phases

4 Phases

Phase 1:1
Phase 2:5
Phase 3:2
+1 more phases

Drug Approvals

9

SFDA:9

Drug Approvals

PEDEA 5MG/ML SOLUTION FOR INJECTION

Approval Date
Jul 18, 2025
SFDA

GENURIN FORT 200 mg tablet

Approval Date
Jul 18, 2025
SFDA

REMEFLIN 8 MG-PEARL

Approval Date
Jul 18, 2025
SFDA

DINTOINA TAB 100MG

Approval Date
Jul 18, 2025
SFDA

REMEFLIN 8 MG-VIAL 3ML.

Approval Date
Jul 18, 2025
SFDA

GENURIN 100MG TAB

Approval Date
Jul 18, 2025
SFDA

VALONTAN TAB 100MG

Approval Date
Jul 18, 2025
SFDA

THEO-DUR TAB 200MG

Approval Date
Jul 18, 2025
SFDA

THEO-DUR TAB 300MG

Approval Date
Jul 18, 2025
SFDA

Clinical Trials

Distribution across different clinical trial phases (10 trials with phase data)• Click on a phase to view related trials

Phase 2
5 (50.0%)
Phase 3
2 (20.0%)
Phase 4
2 (20.0%)
Phase 1
1 (10.0%)

Pasireotide s.c. in Patients With Post-Bariatric Hypoglycaemia

Phase 2
Recruiting
Conditions
Post-Bariatric Hypoglycemia
Interventions
First Posted Date
2023-07-03
Last Posted Date
2025-06-03
Lead Sponsor
RECORDATI GROUP
Target Recruit Count
72
Registration Number
NCT05928390
Locations
🇺🇸

Stanford University School of Medicine, Endocrinology, 800 Welch Road,, Palo Alto, California, United States

🇺🇸

Georgia Clinical Research, LLC, 2878 Five Forks Trickum SW, Suite 2A, Lawrenceville, Georgia, United States

🇺🇸

Northwestern University - Feinberg School of Medicine - Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, United States

and more 28 locations

Osilodrostat for the Treatment of Non-Cushing's Disease Cushing's Syndrome

Completed
Conditions
Cushing's Syndrome
First Posted Date
2022-12-01
Last Posted Date
2025-02-10
Lead Sponsor
RECORDATI GROUP
Target Recruit Count
103
Registration Number
NCT05633953
Locations
🇫🇷

Hôpital Haut-Lévèque, Pessac, France

Non-interventional Study on Osilodrostat in Patients With Endogenous Cushing's Syndrome

Active, not recruiting
Conditions
Endogenous Cushing's Syndrome
Interventions
First Posted Date
2022-05-19
Last Posted Date
2024-07-16
Lead Sponsor
RECORDATI GROUP
Target Recruit Count
206
Registration Number
NCT05382156
Locations
🇺🇸

Barrow Neurological Institute, Phoenix, Arizona, United States

🇺🇸

Emory University School, Atlanta, Georgia, United States

🇺🇸

Northwestern University, Chicago, Illinois, United States

and more 40 locations

Pharmacokinetic (PK), Pharmacodynamic (PD) and Tolerability of Osilodrostat in Pediatric Patients With Cushing's Syndrome

Phase 2
Recruiting
Conditions
Cushing Syndrome
Interventions
First Posted Date
2018-10-17
Last Posted Date
2025-05-14
Lead Sponsor
RECORDATI GROUP
Target Recruit Count
12
Registration Number
NCT03708900
Locations
🇺🇸

University of California San Francisco UCSF, San Francisco, California, United States

🇺🇸

National Institute of Child Health and Human Development, Bethesda, Maryland, United States

🇧🇪

UZ Brussel, Jette, Brussel, Belgium

and more 9 locations

Roll-over Study in Patients With Endogenous Cushing's Syndrome for LCI699

Phase 2
Completed
Conditions
Cushing's Syndrome
Interventions
First Posted Date
2018-07-30
Last Posted Date
2024-12-18
Lead Sponsor
RECORDATI GROUP
Target Recruit Count
127
Registration Number
NCT03606408
Locations
🇺🇸

University of Colorado, Aurora, Colorado, United States

🇺🇸

Emory University School of Medicine G2304 - C2301, Atlanta, Georgia, United States

🇺🇸

Northwestern University SC - LCI699C2301, Chicago, Illinois, United States

and more 53 locations
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News

Recordati Secures Exclusive European Rights to Cardiovascular Drug Vazkepa in $175 Million Deal with Amarin

Recordati has acquired exclusive licensing and supply rights to commercialize Vazkepa (icosapent ethyl) across 59 European countries in a deal worth up to $175 million with Amarin.

FDA Approves First Oral GLP-1 for Weight Management as Q2 2025 Brings Major Endocrinology Advances

Novo Nordisk's 25 mg oral semaglutide for chronic weight management received FDA acceptance in May 2025, potentially becoming the first oral GLP-1 therapy approved for obesity treatment.

FDA Expands Osilodrostat (Isturisa) Indication for Broader Cushing's Syndrome Treatment

The FDA has approved an expanded indication for osilodrostat (Isturisa) to treat endogenous hypercortisolemia in adults with Cushing's syndrome for whom surgery is not an option or has not been curative.

Effective Sponsor Oversight Critical for CRO Partnerships in Clinical Trials, Industry Leaders Emphasize

• Clinical trial sponsors and CROs must establish optimal oversight balance, with experts warning that both excessive and insufficient monitoring can impede trial success and efficiency. • Industry leaders at Veeva's Clinical Operations Outsourcing 2024 Forum stress the importance of early collaboration agreements and transparent communication between sponsors and CROs. • As clinical trials become increasingly complex, particularly in specialized therapies, the need for efficient sponsor oversight becomes more crucial for ensuring trial quality and regulatory compliance.

Recordati Acquires Global Rights to Sanofi's CAD Treatment Enjaymo in $825M Deal

Recordati has secured worldwide rights to Enjaymo, the first and only approved treatment for cold agglutinin disease (CAD), from Sanofi for an upfront payment of $825 million with potential milestone payments of $250 million.

South Korea Accelerates Drug Reimbursement Process with New Pilot Program

South Korea is implementing reforms to reduce drug reimbursement times from approximately 4 years to align more closely with other advanced nations like the US, Japan, and Germany.

Italian Pharmaceutical Market Faces $1.6B Decline as Government Pushes Generic Drug Adoption

Italy's pharmaceutical market is projected to decline from $25.1 billion in 2012 to $23.5 billion by 2020, driven by government austerity measures and strict drug pricing policies.

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