Mirodenafil — Safety, Research, Risks & Legal Status

Not medical advice. Mirodenafil is discussed here for informational and harm-reduction purposes only. We do not endorse use, and any dosing context is informational, not a protocol.

Also known as	Mvix; SK-3530; SK3530
Category	Research Chemical
Trade name (Korea)	Mvix
Development code	SK-3530 / SK3530
Developer	SK Chemicals Life Science, Seongnam, South Korea
Approval date (Korea)	November 2007
Molecular formula (diHCl salt)	C26H39Cl2N5O5S; MW ~604.59 g/mol; CAS 862189-96-6
FDA status	Not approved; no active US regulatory pathway identified
US legal status	Not approved by the FDA for any indication in the United States. Not marketed in Europe or other major Western markets. Approved and commercially available only in South Korea (trade name Mvix, approved November 2007 by SK Chemicals Life Science). In the US, mirodenafil has no approved indication and would be considered an unapproved investigational drug; US patents exist (e.g., USPTO 9549926) covering certain compositions. Acquisition or use outside of approved markets carries regulatory risk under applicable drug laws.

What is Mirodenafil?

Mirodenafil is a second-generation, selective phosphodiesterase type 5 (PDE5) inhibitor developed by SK Chemicals Life Science (Seongnam, South Korea) for the treatment of erectile dysfunction. It belongs to the pyrrolopyrimidinone chemical family - a structural class distinct from the pyrazolopyrimidinone scaffold of sildenafil. It is characterized as second-generation within the PDE5 inhibitor class based on its higher selectivity for PDE5 over other PDE isoforms compared to first-generation agents. It is approved and marketed exclusively in South Korea, with no current FDA approval or apparent active regulatory pathway in the United States.

How it works

Mirodenafil is a potent, reversible, selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). By blocking PDE5-mediated hydrolysis of cGMP in penile smooth muscle, mirodenafil prolongs cGMP signaling downstream of nitric oxide, leading to smooth muscle relaxation and increased arterial inflow to the corpus cavernosum. Its selectivity for PDE5 is reported to be approximately 10-fold greater than that of sildenafil, with correspondingly lower off-target activity against other PDE isoforms (such as PDE6, which is associated with visual disturbances seen with sildenafil). The molecular formula of the dihydrochloride salt is C26H39Cl2N5O5S (MW approximately 604.59 g/mol; CAS 862189-96-6).

Background & history

Mirodenafil was developed by SK Chemicals Life Science in South Korea and received approval in that country in November 2007 under the trade name Mvix, becoming one of the few PDE5 inhibitors developed outside of the US or European pharmaceutical industry to reach clinical approval. An orally disintegrating film formulation was introduced in 2011 to address patients with dysphagia. Multiple randomized controlled trials and Phase IV studies were subsequently conducted in Korean populations, including studies in diabetic men and renally impaired patients. Despite this clinical track record and the existence of US patents, mirodenafil has not been submitted for or granted FDA approval; the absence from the US and EU markets is attributed primarily to business and regulatory strategy rather than to safety disqualification.

What the research says

Human clinical evidence for mirodenafil is substantive relative to many research chemicals but is geographically concentrated in South Korean trial populations. Multicenter, randomized, double-blind, placebo-controlled trials have demonstrated efficacy in erectile dysfunction at doses of 50-100 mg taken as needed, with improvements in erectile function documented across both diabetic and non-diabetic men. A 2014 systematic review (PubMed PMID 24872948) consolidated this evidence base. Additional clinical work includes a 12-week observational study of safety and effectiveness (ClinicalTrials.gov NCT01802359) and a pharmacokinetic study in renally impaired patients (NCT01232010). A network meta-analysis incorporating 179 RCTs found that at the highest studied dose (150 mg), mirodenafil showed elevated adverse event rates relative to comparator PDE5 inhibitors. No serious cardiovascular safety signals emerged in controlled trials, and combination with amlodipine in hypertensive patients was assessed without serious adverse findings. Evidence is robust for the specific Korean populations studied; generalizability to other ethnic populations has not been as thoroughly established.

Reported effects

Facilitates penile erection in men with erectile dysfunction by relaxing corpus cavernosum smooth muscle via cGMP pathway potentiation
Onset of effect studied in as-needed dosing paradigm at 50-100 mg oral doses
Demonstrated efficacy in diabetic ED patients, a population with vascular and neurogenic comorbidity
Orally disintegrating film formulation provides an alternative delivery route for patients with swallowing difficulty
Hemodynamic effects assessed in hypertensive patients concurrently taking amlodipine without serious adverse interaction reported
Higher PDE5 selectivity relative to sildenafil may reduce off-target effects at other PDE isoforms

Dosing & administration (informational)

Published Korean clinical trials studied mirodenafil at oral doses of 50 mg and 100 mg taken as needed for erectile dysfunction, with a 150 mg dose explored in some comparative analyses. A daily-dosing regimen was also investigated in certain studies. These figures are drawn from the clinical trial literature for informational reference only and do not constitute a dosing protocol or medical recommendation. Appropriate dose selection, contraindication screening (particularly regarding nitrate co-administration), and monitoring require evaluation by a licensed clinician.

This is general research/context information, not medical advice or a recommended protocol.

Safety & side effects

Most common adverse events are vasodilatory in nature: flushing (reported range 3.3-24.1% across studies) and headache (1.8-14.8%)
Nasal congestion and oropharyngeal pain reported in clinical trials
Adverse events were predominantly mild to moderate in severity in controlled trials; no serious adverse events reported in available controlled data
No serious cardiovascular events reported in mirodenafil trials, a finding noted as favorable relative to some earlier PDE5 inhibitors
At the highest studied dose (150 mg), network meta-analysis data suggest higher adverse event rates compared to other PDE5 inhibitors
Contraindications expected to parallel the PDE5 inhibitor class broadly - concurrent use with nitrates or nitric oxide donors is a known class contraindication and would be expected to apply
Safety in populations outside South Korean trial cohorts is not well-characterized; renal impairment pharmacokinetics were specifically studied (NCT01232010)

Drug & supplement interactions

A
s
a
P
D
E
5
i
n
h
i
b
i
t
o
r
,
m
i
r
o
d
e
n
a
f
i
l
i
s
e
x
p
e
c
t
e
d
t
o
c
a
r
r
y
t
h
e
c
l
a
s
s
-
w
i
d
e
i
n
t
e
r
a
c
t
i
o
n
c
o
n
c
e
r
n
w
i
t
h
n
i
t
r
a
t
e
s
a
n
d
n
i
t
r
i
c
o
x
i
d
e
d
o
n
o
r
s
(
r
i
s
k
o
f
s
e
v
e
r
e
h
y
p
o
t
e
n
s
i
o
n
)
.
S
p
e
c
i
f
i
c
p
u
b
l
i
s
h
e
d
d
a
t
a
i
n
c
l
u
d
e
a
s
t
u
d
y
o
f
m
i
r
o
d
e
n
a
f
i
l
c
o
-
a
d
m
i
n
i
s
t
e
r
e
d
w
i
t
h
a
m
l
o
d
i
p
i
n
e
(
a
c
a
l
c
i
u
m
c
h
a
n
n
e
l
b
l
o
c
k
e
r
a
n
t
i
h
y
p
e
r
t
e
n
s
i
v
e
)
i
n
h
y
p
e
r
t
e
n
s
i
v
e
E
D
p
a
t
i
e
n
t
s
,
w
h
i
c
h
d
i
d
n
o
t
r
e
v
e
a
l
s
e
r
i
o
u
s
a
d
v
e
r
s
e
h
e
m
o
d
y
n
a
m
i
c
i
n
t
e
r
a
c
t
i
o
n
s
.
A
l
p
h
a
-
b
l
o
c
k
e
r
c
o
-
a
d
m
i
n
i
s
t
r
a
t
i
o
n
i
n
t
e
r
a
c
t
i
o
n
s
h
a
v
e
b
e
e
n
e
x
a
m
i
n
e
d
f
o
r
P
D
E
5
i
n
h
i
b
i
t
o
r
s
g
e
n
e
r
a
l
l
y
a
n
d
a
r
e
e
x
p
e
c
t
e
d
t
o
b
e
r
e
l
e
v
a
n
t
.
C
Y
P
3
A
4
i
n
h
i
b
i
t
o
r
s
a
n
d
i
n
d
u
c
e
r
s
m
a
y
a
f
f
e
c
t
m
i
r
o
d
e
n
a
f
i
l
e
x
p
o
s
u
r
e
,
c
o
n
s
i
s
t
e
n
t
w
i
t
h
t
h
e
P
D
E
5
i
n
h
i
b
i
t
o
r
c
l
a
s
s
,
t
h
o
u
g
h
s
p
e
c
i
f
i
c
i
n
t
e
r
a
c
t
i
o
n
d
a
t
a
i
n
t
h
e
l
i
t
e
r
a
t
u
r
e
a
r
e
l
i
m
i
t
e
d
.
T
h
e
i
n
t
e
r
a
c
t
i
o
n
p
r
o
f
i
l
e
o
u
t
s
i
d
e
o
f
t
h
e
p
u
b
l
i
s
h
e
d
K
o
r
e
a
n
s
t
u
d
i
e
s
i
s
n
o
t
c
o
m
p
r
e
h
e
n
s
i
v
e
l
y
c
h
a
r
a
c
t
e
r
i
z
e
d
.

Who should avoid it

Concurrent use with organic nitrates or nitric oxide donors (class-wide PDE5 inhibitor contraindication)
Use in individuals with known hypersensitivity to PDE5 inhibitors
Use without clinical assessment in men with significant cardiovascular disease, recent stroke, or unstable angina
Co-administration with other PDE5 inhibitors
Use in women or pediatric populations (no studied indication; trials enrolled adult men only)
Obtaining from unregulated research chemical suppliers without independent purity verification

How it is commonly combined

No systematic human data on combination with other erectogenic agents. Combination with other PDE5 inhibitors is contraindicated. The published clinical literature examined mirodenafil as monotherapy and in combination with amlodipine only. Any combination strategy involving vasoactive agents, alpha-blockers, or agents affecting nitric oxide signaling would require clinical supervision given additive hypotensive risk.

Legal & regulatory. Not approved by the FDA for any indication in the United States. Not marketed in Europe or other major Western markets. Approved and commercially available only in South Korea (trade name Mvix, approved November 2007 by SK Chemicals Life Science). In the US, mirodenafil has no approved indication and would be considered an unapproved investigational drug; US patents exist (e.g., USPTO 9549926) covering certain compositions. Acquisition or use outside of approved markets carries regulatory risk under applicable drug laws.

Quality & harm reduction

Find Mirodenafil →

Know your numbers before you research

Order your own bloodwork online — hormone, metabolic and inflammation panels, no doctor visit needed. Know your baselines before and during any protocol. Independent bloodwork is the cheapest insurance there is.

Get tested with Ulta Lab Tests →

Frequently asked questions

Is mirodenafil approved or available in the United States?

No. Mirodenafil has not received FDA approval for any indication and is not commercially marketed in the United States or European Union. It is approved and sold only in South Korea. US patents on certain compositions exist, but no FDA new drug application approval is on record.

How does mirodenafil compare to sildenafil (Viagra)?

Both are PDE5 inhibitors targeting erectile dysfunction through the same cGMP pathway mechanism. Mirodenafil is reported to have approximately 10-fold greater selectivity for PDE5 over other phosphodiesterase isoforms compared to sildenafil, which may reduce certain off-target effects such as visual disturbances associated with PDE6 activity. Clinical efficacy in erectile dysfunction has been demonstrated for both. Direct head-to-head human trials are limited; most mirodenafil data come from Korean trial populations.

What dose is used in clinical studies?

Published trials examined as-needed oral doses of 50 mg and 100 mg, with 150 mg studied in some analyses. These are literature-derived informational figures only - they are not a dosing recommendation. An appropriate dose for any individual requires clinical evaluation, including screening for contraindications such as nitrate use.

What are the main side effects documented in trials?

The most commonly reported adverse events are consistent with the PDE5 inhibitor class: flushing (reported in 3.3-24.1% of subjects depending on study and dose), headache (1.8-14.8%), and nasal congestion with oropharyngeal pain. Most events were mild to moderate. No serious adverse events were reported in controlled trials. At 150 mg, network meta-analysis data suggest higher adverse event rates relative to other PDE5 inhibitors.

Is there evidence of cardiovascular risk?

Controlled trials reported no serious cardiovascular events with mirodenafil. A specific study examined co-administration with amlodipine in hypertensive patients without serious hemodynamic adverse findings. However, the class-wide PDE5 inhibitor contraindication with nitrates and nitric oxide donors applies and represents a serious interaction risk if those agents are used concurrently. Men with significant cardiovascular disease should be evaluated by a clinician before using any PDE5 inhibitor.

Is mirodenafil being studied for any indication other than erectile dysfunction?

A US patent (USPTO 9549926) covers compositions of mirodenafil for pulmonary hypertension, reflecting that PDE5 inhibitors as a class have established use in pulmonary arterial hypertension (e.g., sildenafil/Revatio). However, published clinical trial data for mirodenafil in pulmonary hypertension specifically are not established in the available literature; this appears to be a patent-level claim rather than a completed clinical program.

References & further reading

PubMed: mirodenafil systematic review erectile dysfunction (PMID 24872948)
PubMed: mirodenafil SK-3530 PDE5 inhibitor Korea efficacy safety review PMC4772359
ClinicalTrials.gov: NCT01802359 mirodenafil safety effectiveness Korean ED patients
ClinicalTrials.gov: NCT01232010 mirodenafil pharmacokinetics renal impairment
PubMed: mirodenafil hemodynamics hypertensive patients amlodipine combination