Last reviewed 2026-05-14 · How we verify

Immediate high-intensity statin

Beijing Tiantan Hospital · Phase 3 active Small molecule

Immediate high-intensity statin is a HMG-CoA reductase inhibitor (statin) Small molecule drug developed by Beijing Tiantan Hospital. It is currently in Phase 3 development for Acute coronary syndrome or high-risk cardiovascular disease requiring rapid LDL cholesterol reduction, Hypercholesterolemia in patients requiring immediate intensive lipid lowering. Also known as: Immediate Atorvastatin.

Statins inhibit HMG-CoA reductase to reduce cholesterol synthesis and lower LDL cholesterol levels.

Statins inhibit HMG-CoA reductase to reduce cholesterol synthesis and lower LDL cholesterol levels. Used for Acute coronary syndrome or high-risk cardiovascular disease requiring rapid LDL cholesterol reduction, Hypercholesterolemia in patients requiring immediate intensive lipid lowering.

Likelihood of approval

56.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Cardiovascular Phase 3 risk -2.0pp
Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	Immediate high-intensity statin
Also known as	Immediate Atorvastatin
Sponsor	Beijing Tiantan Hospital
Drug class	HMG-CoA reductase inhibitor (statin)
Target	HMG-CoA reductase
Modality	Small molecule
Therapeutic area	Cardiovascular
Phase	Phase 3

Mechanism of action

High-intensity statins potently block the enzyme HMG-CoA reductase, which catalyzes an early rate-limiting step in hepatic cholesterol biosynthesis. This leads to upregulation of LDL receptors on hepatocytes, increasing clearance of LDL particles from the bloodstream and substantially reducing circulating LDL cholesterol. The immediate high-intensity formulation is designed for rapid onset of lipid-lowering effects in acute cardiovascular settings.

Approved indications

Acute coronary syndrome or high-risk cardiovascular disease requiring rapid LDL cholesterol reduction
Hypercholesterolemia in patients requiring immediate intensive lipid lowering

Common side effects

Muscle myalgia or myopathy
Elevated liver transaminases
Headache
Gastrointestinal upset

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Immediate high-intensity statin CI brief — competitive landscape report
Immediate high-intensity statin updates RSS · CI watch RSS
Beijing Tiantan Hospital portfolio CI

Frequently asked questions about Immediate high-intensity statin

What is Immediate high-intensity statin?

Immediate high-intensity statin is a HMG-CoA reductase inhibitor (statin) drug developed by Beijing Tiantan Hospital, indicated for Acute coronary syndrome or high-risk cardiovascular disease requiring rapid LDL cholesterol reduction, Hypercholesterolemia in patients requiring immediate intensive lipid lowering.

How does Immediate high-intensity statin work?

Statins inhibit HMG-CoA reductase to reduce cholesterol synthesis and lower LDL cholesterol levels.

What is Immediate high-intensity statin used for?

Immediate high-intensity statin is indicated for Acute coronary syndrome or high-risk cardiovascular disease requiring rapid LDL cholesterol reduction, Hypercholesterolemia in patients requiring immediate intensive lipid lowering.

Who makes Immediate high-intensity statin?

Immediate high-intensity statin is developed by Beijing Tiantan Hospital (see full Beijing Tiantan Hospital pipeline at /company/beijing-tiantan-hospital).

Is Immediate high-intensity statin also known as anything else?

Immediate high-intensity statin is also known as Immediate Atorvastatin.

What drug class is Immediate high-intensity statin in?

Immediate high-intensity statin belongs to the HMG-CoA reductase inhibitor (statin) class. See all HMG-CoA reductase inhibitor (statin) drugs at /class/hmg-coa-reductase-inhibitor-statin.

What development phase is Immediate high-intensity statin in?

Immediate high-intensity statin is in Phase 3.

What are the side effects of Immediate high-intensity statin?

Common side effects of Immediate high-intensity statin include Muscle myalgia or myopathy, Elevated liver transaminases, Headache, Gastrointestinal upset.

What does Immediate high-intensity statin target?

Immediate high-intensity statin targets HMG-CoA reductase and is a HMG-CoA reductase inhibitor (statin).

Drug class: All HMG-CoA reductase inhibitor (statin) drugs
Target: All drugs targeting HMG-CoA reductase
Manufacturer: Beijing Tiantan Hospital — full pipeline
Therapeutic area: All drugs in Cardiovascular
Indication: Drugs for Acute coronary syndrome or high-risk cardiovascular disease requiring rapid LDL cholesterol reduction
Indication: Drugs for Hypercholesterolemia in patients requiring immediate intensive lipid lowering
Also known as: Immediate Atorvastatin

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing