TheraRadar
Data updated: Jun 28, 2026

BIORPHEN (phenylephrine hydrochloride) · Dr. Reddy's

Cardiovascular Approved 2019-10-21

BIORPHEN is FDA-approved to treat 8 conditions (same as IMMPHENTIV).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents
2
Indications
--
Phase 3 Trials
6
Years on Market

Details

Status
Discontinued
First Approved
2019-10-21
Routes
INTRAVENOUS
Dosage Forms
SOLUTION

Companies

Dr. Reddy's
Active Ingredient: PHENYLEPHRINE HYDROCHLORIDE

BIORPHEN Approval History

2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
6 FDA actions from 2019 to 2024 · 1 indication expansions
Apr 2024 SUPPL
Mfg · Manufacturing (CMC)
FDA Letter Label
Mar 2021 SUPPL
Efficacy
FDA Letter Label
Oct 2019 ORIGINAL
Update · Type 5 - New Formulation or New Manufacturer
FDA Letter Label

What BIORPHEN Treats

8 indications

BIORPHEN is approved for 8 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.

Same approved indications as IMMPHENTIV (same active ingredient).

Source: FDA Label
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Clinical Trial Registry

2 trials
Trial Sponsor ID Phase Status Title
NCT05997732 STARS Pro00126600 Ph 4 recruiting Sympathetic Neurovascular Transduction: Role of Adrenergic Receptors and Sex Differences
NCT03098680 PRIME PRIME (A094136) Ph 1 terminated A Study of the Pharmacokinetic and Pharmacodynamic Responses in Healthy and Altered Human Cardiovascular Systems
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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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.

BIORPHEN FDA Label Details

Indications & Usage

FDA Label (PDF)

BIORPHEN is FDA-approved to treat 8 conditions — same approved indications as IMMPHENTIV.

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Data Sources

FDA Approval: NDA212909 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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