Sdamlo

(Amlodipine Besylate)

ApprovedSmall molecule

VViatris Specialty LLC

Sdamlo is one of 77 small molecule programs targeting Liver Transplant. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Liver TransplantActive, not recruiting

HypertensionActive, not recruiting

Liver TransplantApproved

Active, not recruiting

HypertensionApproved

Active, not recruiting

Competition

Competitive Landscape

161 competitors in Hypertension

#DrugCompanyPhaseTrials

Foundayo

Eli Lilly

Phase 3

3 2

Nitrostat

VViatris Specialty LLC

Phase 3

5 3

Baxfendy

AstraZeneca

Phase 3

3 4

Sdamlo

VViatris Specialty LLC

Approved

7 5

Alka-Seltzer

AAbbott

Phase 3

1 6

HCP1803-3

Hanmi Pharmaceutical Company Limited

Phase 3

1 7

Avastin

Roche

Preclinical

1 8

Winrevair

Alphagan

Deltavit

HHyundai Pharmaceutical Co., LTD.

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2027

PreclinicalRecruiting

Primary Aldosteronism

NCT07884955

Q4 2028

ApprovedRecruiting

Hypertension

NCT07876544

Q2 2029

Post-ApprovalRecruiting

Hypertension

NCT04974151

Q2 2030

Post-ApprovalRecruiting

Hypertension

NCT04974138

Clinical

Trials by Indication[1]

Hypertension7 trials

China Stroke Primary Prevention Trial 2 for Participants With H-type Hypertension and MTHFR 677 CC/CT Genotype (CSPPT2-CC/CT)

Recruiting·SShenzhen Ausa Pharmed Co.,Ltd·Phase 4·NCT04974138·32,000 enrolled

Perindopril Amlodipine for the Treatment of Hypertension

Completed·SSymplmed Pharmaceuticals LLC·Phase 3·NCT01556997·837 enrolled

BLOCKade of Calcium Channels and Beta Adrenergic Receptors for the Treatment of Hypertension in HFpEF

Completed·UUniversity of Pennsylvania·Phase 4·NCT04434664·50 enrolled

Show 4 more trials

China Stroke Primary Prevention Trial 2 for Participants With Hypertension and MTHFR 677 TT Genotype

Recruiting·SShenzhen Ausa Pharmed Co.,Ltd·Phase 4·NCT04974151·24,000 enrolled

Efficacy and Safety Study of S-Amlodipine Gentisate Compared to Amlodipine Besylate to Treat Mild-to-Moderate Hypertension

Completed·SSK Chemicals Co., Ltd.·Phase 3·NCT00289406·110 enrolled

MK-0954E Study in Participants With Hypertension (MK-0954E-357)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT01302691·327 enrolled

A Multicenter, Randomized, Double-Blind, Parallel-Controlled Phase IV Clinical Trial to Evaluate the Efficacy and Safety of Sitogilun Malate Tablets Combined With Amlodipine Besylate Tablets in Patients With Mild to Moderate Essential Hypertension and Risk of Early Kidney Damage

Recruiting·SShanghai Jiao Tong University School of Medicine·Approved·NCT07876544·456 enrolled

Fasting Conditions2 trials

Amlodipine 10 mg Tablets Under Fasting Conditions

Completed· Teva logo

Teva·Phase 1·NCT00841542·28 enrolled

An Comparative Pharmacokinetic Study of Amlodipine Besylate Controlled-release Tablets,China in Normal, Healthy, Adult, Human Subjects Under Fasting Conditions

Unknown status·OOverseas Pharmaceuticals, Ltd.·Phase 1·NCT05667818·16 enrolled

Adult Subject2 trials

Study to Evaluate the Bioavailability of the Test Formulation of Amlodipine 10 mg Tablets (Torrent Pharmaceuticals Limited) Compared to a 10 mg Dose of Norvasc® (Pfizer) in 22 Fasted, Healthy Adult Subjects

Completed·TTorrent Pharmaceuticals Limited·Phase 1·NCT00932763

Study to Evaluate the Bioavailability of the Test Formulation of Amlodipine 10 mg Tablets (Torrent Pharmaceuticals Limited) Compared to a 10 mg Dose of Norvasc® (Pfizer) in 18 Fed, Healthy Adult Subjects

Completed·TTorrent Pharmaceuticals Limited·Phase 1·NCT00932880

AML1 trial

Amlodipine 10 mg Tablets Under Fed Conditions

Completed· Teva logo

Teva·Phase 1·NCT00841815·28 enrolled

Liver Transplant1 trial

Mechanism of Hypertension Treatments in Liver Transplant Recipients (BLOCK LTR-HTN)

Withdrawn·NNorthwestern University·Phase 4·NCT05275907

5 more indications

Blood Pressure1 trial

A Multi-Risk Factor Strategy vs a Guideline-Based Approach in Achieving Blood Pressure and Lipid Goals in Hypertensives at Extra Risk

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 4·NCT00412113·245 enrolled

Hemodialysis1 trial

Evaluation of Amlodipine Pharmacokinetics in Patients Receiving Hi Flux Hemodialysis

Withdrawn·UUniversity of Michigan··NCT03722381

Lactation1 trial

Pharmacokinetics of Amlodipine Besylate at Delivery and During Lactation

Completed·UUniversity of Texas Southwestern Medical Center·Phase 4·NCT02353806·16 enrolled

Arterial Stiffness1 trial

Nifedipine GITS and Amlodipine Besylate on Recovery of Blood Pressure Rhythm and Arterial Stiffness

Terminated·JJing Liu·Phase 4·NCT02940548·99 enrolled

Primary Aldosteronism1 trial

A Randomized Controlled Study Comparing Inclisiran Plus Spironolactone Versus Statin Plus Spironolactone for Primary Aldosteronism

Recruiting·TThird Military Medical University·Preclinical·NCT07884955·50 enrolled

Regulatory

FDA Approval Timeline[4]

Jul 31, 1992

NORVASC

NDA NDA019787

Oct 31, 2003

AMVAZ

NDA NDA021435

Sep 27, 2007

AMLODIPINE BESYLATE

NDA NDA022026

Jul 8, 2019

KATERZIA

NDA NDA211340

Feb 24, 2022

NORLIQVA

NDA NDA214439

Jul 24, 2025

SDAMLO

NDA NDA219531

Sources

References

[1]
ClinicalTrials.gov — 18 trial records for Amlodipine Besylate. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Amlodipine Besylate compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Amlodipine Besylate. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA219531). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Viatris Specialty LLC company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: VViatris Specialty LLC

Sdamlo

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2027

Q4 2028

Q2 2029

Q2 2030

Trials by Indication[1]

Hypertension7 trials

Fasting Conditions2 trials

Adult Subject2 trials

AML1 trial

Liver Transplant1 trial

Blood Pressure1 trial

Hemodialysis1 trial

Lactation1 trial

Arterial Stiffness1 trial

Primary Aldosteronism1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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