What is CYPROLARA used for?

CYPROLARA is an FDA-approved medication. See full prescribing information for approved uses.

Is CYPROLARA FDA approved?

Yes, CYPROLARA is FDA approved (first approved 2021-02-24) and manufactured by QUAGEN.

CYPROLARA is manufactured by QUAGEN.

Data updated: Nov 8, 2026

CYPROLARA (cyproheptadine hydrochloride) · QUAGEN

Approved 2021-02-24

Jump to: Indications Approvals Trials Competitors Safety Patents

Indication

Phase 3 Trials

Years on Market

Details

Status: Prescription
First Approved: 2021-02-24
Routes: ORAL
Dosage Forms: TABLET

Companies

QUAGEN

Active Ingredient: CYPROHEPTADINE HYDROCHLORIDE

CYPROLARA Approval History

2022

2023

2024

2025

2026

Original

New Indication

New Form

Label Update

2 FDA actions from 2021 to 2026

Oct 2026 SUPPL

Mfg · Manufacturing (CMC)

Feb 2021 ORIGINAL

Update

What CYPROLARA Treats

1 FDA approvals

Originally approved for its first indication in 2021 .

Other (1)

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Clinical Trial Registry

2 trials

Trial	Sponsor ID	Phase	Status	Title
NCT01132547 results posted	SCUSF 0703 SCUSF-0703, 5U10CA081920-11	Ph 3	terminated	Cyproheptadine in Preventing Weight Loss in Children Receiving Chemotherapy for Cancer
NCT00949117 results posted	SCUSF 0802 SCUSF-0802, 5U10CA081920-11	Ph 2	terminated	Cyproheptadine Hydrochloride and Nutritional Supplementation in Treating Young Patients With Weight Loss With Cancer

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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

| Show all trials (incl. adjuvant)

Understanding FDA Approval Types

Count	Type	What it means
-	ORIG	Original approval - drug first enters market
-	SUPPL - Efficacy	New indication (new disease/condition approved)
-	SUPPL - Labeling	Label text changes (warnings, dosing updates)
-	SUPPL - Manufacturing	Production changes (new facility)
-	SUPPL - Chemistry	Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

CYPROLARA FDA Label Details

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Data Sources

FDA Approval: ANDA212491 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.