Last reviewed 2026-05-23 · How we verify

tanshinone

Heilongjiang University of Chinese Medicine · Phase 1 active Small molecule ✓ Verified May 2026

tanshinone is a Small molecule drug developed by Heilongjiang University of Chinese Medicine. It is currently in Phase 1 development.

Tanshinone is a naturally occurring small molecule compound that can be isolated from Salvia miltiorrhiza. It has been studied in clinical trials for conditions such as pulmonary hypertension, cardiovascular diseases, and lung diseases, including a study on its efficacy and safety in treating pulmonary hypertension.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 1 → approval rate +9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2033–2036	—
EMA	EU	2034–2037	+0.7 yr
MHRA	GB	2034–2037	+0.7 yr
Health Canada	CA	2034–2038	+0.9 yr
TGA	AU	2034–2038	+1.2 yr
PMDA	JP	2034–2038	+1.5 yr
NMPA	CN	2035–2039	+2.3 yr
MFDS	KR	2034–2038	+1.4 yr
CDSCO	IN	2034–2039	+1.8 yr
ANVISA	BR	2035–2039	+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	tanshinone
Sponsor	Heilongjiang University of Chinese Medicine
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Clinical Study of Tanshinone Capsules Against COVID-19 (PHASE2, PHASE3)
Sodium Tanshinone IIA Sulfonate in Left Ventricular Remodeling Secondary to Acute Myocardial Infarction (PHASE4)
Efficacy and Safety Study of Sodium Tanshinone IIA Sulfonate on Pulmonary Hypertension (PHASE2, PHASE3)
Tanshinone in Polycystic Ovary Syndrome (NA)

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:

tanshinone CI brief — competitive landscape report
tanshinone updates RSS · CI watch RSS
Heilongjiang University of Chinese Medicine portfolio CI

Frequently asked questions about tanshinone

What is tanshinone?

tanshinone is a Small molecule drug developed by Heilongjiang University of Chinese Medicine.

Who makes tanshinone?

tanshinone is developed by Heilongjiang University of Chinese Medicine (see full Heilongjiang University of Chinese Medicine pipeline at /company/heilongjiang-university-of-chinese-medicine).

What development phase is tanshinone in?

tanshinone is in Phase 1.

Manufacturer: Heilongjiang University of Chinese Medicine — full pipeline
Therapeutic area: All drugs in Other

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