> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/drospirenone-9b602c10-48da-4ba8-ace9-5b9f942ad491
> Record changed: 2026-10-13

# Drospirenone

Highest phase reached

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1509)

Drug type

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1509)

First approval year

2001

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1509)

## Development status

**First approval year**

2001

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1509)

**Listing at source**

Listed

**Highest phase reached**

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1509)

## Names and chemistry

**Drug type**

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1509)

**Drug name**

Drospirenone

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1509)

**Molecular weight**

366.5

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1509)

**Structure (SMILES)**

C\[C@\]12CCC(=O)C=C1\[C@@H\]1C\[C@@H\]1\[C@H\]1\[C@@H\]3\[C@@H\]4C\[C@@H\]4\[C@@\]4(CCC(=O)O4)\[C@@\]3(C)CC\[C@@H\]12

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1509)

### Brand names (14)

- drospirenone component of angeliq
- Drospirenone component of angeliq
- drospirenone component of beyaz
- Drospirenone component of beyaz
- drospirenone component of nextstellis
- Drospirenone component of nextstellis
- drospirenone component of safyral
- Drospirenone component of safyral
- drospirenone component of yasmin
- Drospirenone component of yasmin
- drospirenone component of yaz
- Drospirenone component of yaz
- slynd
- Slynd

### Other names (55)

- (6R,7R,8R,9S,10R,13S,14S,15S,16S,17S)-1,3',4',6,6A,7,8,9,10,11,12,13,14,15,15A,16-HEXADECAHYDRO-10,13-DIMETHYLSPIRO-(17H-DICYCLOPROPA(6,7:15,16)CYCLOPENTA(A)PHENANTHRENE-17,2'(5'H)-FURAN)-3,5'(2H)-DIONE
- 0 25mg drsp 0 5mg e2 bay86 4891
- 17 hydroxy 6β 7β 15β 16β dimethylene 3 oxo 17α pregn 4 ene 21 carboxylic acid γ lactone
- 17-Hydroxy-6β,7β:15β,16β-dimethylene-3-oxo-17α-pregn-4-ene-21-carboxylic acid, γ-lactone
- 6r 7r 8r 9s 10r 13s 14s 15s 16s 17s 1 3 4 6 6a 7 8 9 10 11 12 13 14 15 15a 16 hexadecahydro 10 13 dimethylspiro 17h dicyclopropa 6 7 15 16 cyclopenta a phenanthrene 17 2 5 h furan 3 5 2h dione
- angeliq component drospirenone
- ANGELIQ COMPONENT DROSPIRENONE
- beyaz component drospirenone
- BEYAZ COMPONENT DROSPIRENONE
- drospirenona
- Drospirenona
- drospirenone
- Drospirenone
- DROSPIRENONE \[EP MONOGRAPH\]
- drospirenone \[INN\]
- DROSPIRENONE \[JAN\]
- DROSPIRENONE \[MART.\]
- DROSPIRENONE \[MI\]
- DROSPIRENONE \[ORANGE BOOK\]
- DROSPIRENONE \[USAN\]
- DROSPIRENONE \[USP MONOGRAPH\]
- DROSPIRENONE \[USP-RS\]
- DROSPIRENONE \[VANDF\]
- Drospirenone \[WHO-DD\]
- Drospirenone 4 MG

And 30 more, listed on the interactive page.

## Identifiers

**ATC classification codes**

- G03AC10

Sources for recorded values

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1509)

**CAS registry numbers**

- 67392-87-4

**ChEMBL ID**

CHEMBL1509

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1509)

**InChIKey**

METQSPRSQINEEU-HXCATZOESA-N

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1509)

**PubChem compound IDs**

- 68873

**RxNorm IDs (RxCUI)**

- 11636

**FDA ingredient codes (UNII)**

- N295J34A25

## Regulatory information

### United States

**Applicant**

BAYER HLTHCARE

**Approval date**

28 Sept 2005

**Application number**

NDA021355

### Other regulatory facts

**Patents**

30

**Designations**

0

**Earliest recorded loss of exclusivity**

28 Jun 2031

**First in class**

No

**Fast track**

No

**Breakthrough designation**

No

**Orphan designation**

No

**Priority review**

No

**Orphan exclusivity**

No

**Accelerated approval**

No

**Availability**

Prescription only

## Pharmacology

### Drug classification

**Pharmacology name**

drospirenone

**Type**

Synthetic organic

**Drug name stem**

\-renone

**Approval recorded by Guide to Pharmacology**

Yes

#### Administration routes

- Oral

### Mechanisms of action (3)

- **Mechanism**  
Progesterone receptor agonist

**Action type**  
Agonist

**Target**  
Progesterone receptor

**Protein identifier**  
P06401
- **Action**  
Antagonist

**Action type**  
Antagonist

**Target**  
Mineralocorticoid receptor

**Gene symbol**  
NR3C2

**Protein identifier**  
P08235

**Primary target**  
Yes
- **Mechanism**  
Mineralocorticoid receptor antagonist

**Action type**  
Antagonist

**Target**  
Mineralocorticoid receptor

**Protein identifier**  
P08235

### Open Targets mechanisms (2)

- **Mechanism**  
Progesterone receptor agonist

**Action type**  
Agonist

**Target**  
Progesterone receptor
- **Mechanism**  
Mineralocorticoid receptor antagonist

**Action type**  
Antagonist

**Target**  
Mineralocorticoid receptor

### DrugCentral mechanisms (2)

- **Action type**  
Agonist

**Gene symbol**  
PGR

**Protein identifier**  
P06401

**Organism**  
Homo sapiens

**Target development level**  
Clinical
- **Action type**  
Antagonist

**Gene symbol**  
NR3C2

**Protein identifier**  
P08235

**Organism**  
Homo sapiens

**Target development level**  
Clinical

### Investigated indications (9)

- **Condition**  
Polycystic Ovary Syndrome

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000660

**Subject identifier**  
D011085
- **Condition**  
Obesity

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0001073

**Subject identifier**  
D009765
- **Condition**  
Acne Vulgaris

**Highest recorded phase**  
4

**Condition identifier**  
EFO:0003894

**Subject identifier**  
D000152
- **Condition**  
Bulimia Nervosa

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0005204

**Subject identifier**  
D052018
- **Condition**  
Bulimia

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0005924

**Subject identifier**  
D002032
- **Condition**  
Hidradenitis Suppurativa

**Highest recorded phase**  
2

**Condition identifier**  
EFO:1000710

**Subject identifier**  
D017497
- **Condition**  
Dysmenorrhea

**Highest recorded phase**  
3

**Condition identifier**  
HP:0100607

**Subject identifier**  
D004412
- **Condition**  
Depressive Disorder

**Highest recorded phase**  
2

**Condition identifier**  
MONDO:0002050

**Subject identifier**  
D003866
- **Condition**  
Premenstrual Syndrome

**Highest recorded phase**  
2

**Condition identifier**  
MONDO:0004169

**Subject identifier**  
D011293

### Open Targets indications (40)

- **Condition identifier**  
EFO\_0000195
- **Condition identifier**  
EFO\_0000660

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0001065
- **Condition identifier**  
EFO\_0003894
- **Condition identifier**  
EFO\_0009006
- **Condition identifier**  
EFO\_0009520
- **Condition identifier**  
EFO\_0009520

**Highest recorded phase**  
4
- **Condition identifier**  
EFO\_1000710

**Highest recorded phase**  
2
- **Condition identifier**  
GO\_0042697
- **Condition identifier**  
HP\_0000132

**Highest recorded phase**  
1
- **Condition identifier**  
HP\_0000789
- **Condition identifier**  
HP\_0000855
- **Condition identifier**  
HP\_0000858
- **Condition identifier**  
HP\_0001007

**Highest recorded phase**  
2
- **Condition identifier**  
HP\_0001513

**Highest recorded phase**  
3
- **Condition identifier**  
HP\_0002829
- **Condition identifier**  
HP\_0003326
- **Condition identifier**  
HP\_0008209
- **Condition identifier**  
HP\_0012531
- **Condition identifier**  
HP\_0012531

**Highest recorded phase**  
4
- **Condition identifier**  
HP\_0100607
- **Condition identifier**  
HP\_0100607

**Highest recorded phase**  
4
- **Condition identifier**  
MONDO\_0001119
- **Condition identifier**  
MONDO\_0001134

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0002050

And 15 more, listed on the interactive page.

### Reported adverse events (19)

- **Event**  
bleeding time prolonged

**Reports**  
2

**Reporting signal score**

7.70076
- **Event**  
carotid artery thrombosis

**Reports**  
3

**Reporting signal score**

14.028
- **Event**  
cerebral venous sinus thrombosis

**Reports**  
2

**Reporting signal score**

9.0885
- **Event**  
dyspareunia

**Reports**  
4

**Reporting signal score**

14.1657
- **Event**  
electrocardiogram qt interval abnormal

**Reports**  
2

**Reporting signal score**

9.12609
- **Event**  
intermenstrual bleeding

**Reports**  
2

**Reporting signal score**

9.61889
- **Event**  
menorrhagia

**Reports**  
6

**Reporting signal score**

13.2714
- **Event**  
metrorrhagia

**Reports**  
12

**Reporting signal score**

42.3278
- **Event**  
oligomenorrhoea

**Reports**  
2

**Reporting signal score**

7.93574
- **Event**  
ovarian cancer

**Reports**  
3

**Reporting signal score**

9.57963
- **Event**  
pituitary gland operation

**Reports**  
1

**Reporting signal score**

8.11198
- **Event**  
postmenopausal haemorrhage

**Reports**  
4

**Reporting signal score**

16.6657
- **Event**  
pregnancy on oral contraceptive

**Reports**  
8

**Reporting signal score**

41.5958
- **Event**  
psychotic disorder

**Reports**  
10

**Reporting signal score**

20.6804
- **Event**  
suppressed lactation

**Reports**  
5

**Reporting signal score**

26.1898
- **Event**  
thrombophlebitis superficial

**Reports**  
3

**Reporting signal score**

9.55389
- **Event**  
urticaria localised

**Reports**  
2

**Reporting signal score**

13.0791
- **Event**  
uterine polyp

**Reports**  
2

**Reporting signal score**

7.55753
- **Event**  
vaginal haemorrhage

**Reports**  
5

**Reporting signal score**

8.89585

### Trial references (11)

- NCT00089414  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00089414)
- NCT00569244  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00569244)
- NCT00651469  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00651469)
- NCT00656981  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00656981)
- NCT00722761  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00722761)
- NCT00818519  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00818519)
- NCT00722800  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00722800)
- NCT00948402  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00948402)
- NCT01581814  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01581814)
- NCT04278755  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04278755)
- NCT06039826  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06039826)

## Dosing

**Route**

Oral

**How often**

Once daily

### Conditions of use (3)

- Preferably after evening meal or at bedtime
- Take in the same order on the blister pack
- Take without regard to meals

## Chemical properties

**Hydrogen bond acceptors**

3

**Hydrogen bond donors**

0

**Polar surface area**

43.37

**Calculated partition coefficient (ALogP)**

4.31

**Calculated partition coefficient (XLogP)**

3.5

**Prodrug**

No

**Chirality**

Single enantiomer

**Inorganic**

No

**Rule-of-five violations**

0

**Rotatable bonds**

0

**Heavy atoms**

27

**Molecular formula**

C24H30O3

**Monoisotopic mass**

366.21949481

**Natural product**

Yes

## National Drug Codes

- 50419-482
- 50419-483

## Evidence counts

**Recorded assays**

903

**Active assays**

57

### Active assay types (4)

- Confirmatory
- Other
- Screening
- Summary

## Pharmacologic actions

- Mineralocorticoid Receptor Antagonists  
Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D000451.html)

## Biological measurements

### Observed measurements

#### Oral bioavailability

**Median**

76

**Mean**

76

**Minimum**

76

**Maximum**

76

**Unit**

%

**Assays**

1

**Standard deviation**

0

**Summary method**

median

**Censored results excluded**

0

**Other units excluded**

0

**Unknown units excluded**

0

#### Measurement types

- F

## Related records

### Trials (95)

- "E4/DRSP Endocrine Function, Metabolic Control and Hemostasis Study"
- "Quick-starting" of a New Combined Hormonal Contraceptive Pills, 15 mg Estetrol/3 mg Drospirenone VS 20 mcg Ethinylestradiol/75 mcg Gestodene Focusing on Ovulation Inhibition
- A Drug-Drug Interaction Study Between HS-10374 Tablets and Drospirenone and Ethinyl Estradiol Tablets(Yasmin®)
- A Drug-drug Interaction Study of Vorasidenib and a Combined Oral Contraceptive in Healthy Female Participants
- A Drug-drug Interaction Study to Evaluate the Effects of Pelabresib on the Pharmacokinetics of Repaglinide, Midazolam, and Combined Oral Contraceptive in Patients With Advanced Malignancies
- A Randomized Feasibility Trial Comparing Drospirenone and Norethindrone for Postpartum Hypertension Management in Preeclampsia
- A Study in Healthy Female Participants to Investigate the Effect of JNJ-56136379 at Steady-state on the Single-dose Pharmacokinetics of Ethinylestradiol and Drospirenone (Oral Contraceptive) and on the Single-dose Pharmacokinetics of Midazolam (Probe Substrate for Cytochrome P450 3A4)
- A Study of LY3437943 in Postmenopausal Female Participants Who Are Overweight or Obese
- A Study of Milvexian in Healthy Adult Females
- A Study to Evaluate Inhibition of Ovulation of Two Oral Estrogen/Progestogen Regimens in Healthy, Young Females Over a Period of 3 Treatment Cycles
- A Study to Evaluate Ovarian Follicular Activity and Hormone Levels for DR-102 Compared to Two 28-Day Oral Contraceptives
- A Study to Evaluate the Effectiveness of NuvaRing® to Prevent Pregnancies in Chinese Women (P06450)
- A Study to Examine the Safety and Efficacy of Drospirenone and Ethinyl Estradiol (YAZ) Versus Placebo In HS
- A Study to Investigate the Effects of BMS-986278 on Drospirenone and Ethinyl Estradiol Drug Levels in Healthy Female Participants
- A Study to Investigate the Interaction Between JNJ-64155806 and Ethinylestradiol/Drospirenone in Healthy Females
- Aspirin for the Management of Endometriosis-associated Pelvic Pain
- Assess Satisfaction of Patients and Physicians With Results of Yaz Plus Treatment for 13 Cycles
- Assessment of the Pharmacodynamic Effect on Plasma Folate and Red Blood Cell Folate and Comparison of the Folate Metabolites During the 24 Weeks of Treatment (Yasmin + Metafolin Versus Yasmin + Folic Acid) Followed by a 20 Week Elimination Phase of Folate
- Binge Eating & Birth Control
- Can Drospirenone be Used to Prevent LH Surge in Controlled Ovarian Stimulation in PCOS?!

### Approved for (1)

- [Acne](https://trialight.com/data/condition/acne-02478aa3-966b-5ffb-a257-6dbe85c14e58.md)

### In development for (8)

- Binge eating disorder Phase 2
- Bulimia nervosa Phase 2
- [Depressive disorder](https://trialight.com/data/condition/depressive-disorder-7618feda-3f90-5521-94e1-99f7100e8324.md) Phase 2
- Dysmenorrhea Phase 3
- [Hidradenitis suppurativa](https://trialight.com/data/condition/hidradenitis-suppurativa-c1030a8d-4971-5d31-b030-aa19715eb7a2.md) Phase 2
- [Obesity disorder](https://trialight.com/data/condition/obesity-disorder-f3b57dc0-68ac-555c-8f13-0d81e595d9cb.md) Phase 1
- Polycystic ovary syndrome Phase 3
- Premenstrual tension Phase 2

### Other linked conditions (2)

- Adenomyosis
- [Endometriosis](https://trialight.com/data/condition/endometriosis-3a5471b6-6d24-50b8-b1e6-8803dd78b0db.md)

### Targets (2)

- [NR3C2](https://trialight.com/data/target/nr3c2-ddf600eb-ddcf-5af5-b7a0-935d2b5ed817.md) Mineralocorticoid receptor antagonist
- [PGR](https://trialight.com/data/target/pgr-4e536b31-8799-5ace-a427-be36fd8a5f9f.md) Progesterone receptor agonist

---

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