Low-dose Clomiphene — Competitive Intelligence Brief

Low-dose Clomiphene (Low-dose Clomiphene) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Selective estrogen receptor modulator (SERM). Area: Endocrinology.

marketed Selective estrogen receptor modulator (SERM) Estrogen receptor (ER-α and ER-β) Endocrinology Small molecule

Target snapshot

Low-dose Clomiphene (Low-dose Clomiphene) — Weill Medical College of Cornell University. Low-dose clomiphene is a selective estrogen receptor modulator (SERM) that blocks negative feedback on the hypothalamic-pituitary-gonadal axis, stimulating endogenous testosterone production in men.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Low-dose Clomiphene TARGET	Low-dose Clomiphene	Weill Medical College of Cornell University	marketed	Selective estrogen receptor modulator (SERM)	Estrogen receptor (ER-α and ER-β)
tamoxifen citrate (Tamoxifen)	tamoxifen citrate (Tamoxifen)	H. Lee Moffitt Cancer Center and Research Institute	marketed	Selective estrogen receptor modulator (SERM)	Estrogen receptor alpha (ERα)
Toremifene; Anastrozole	Toremifene; Anastrozole	Peking Union Medical College Hospital	marketed	Selective estrogen receptor modulator (SERM) + aromatase inhibitor (AI)	Estrogen receptor (ER); aromatase (CYP19A1)
Clomiphene citrate and Estradiol	Clomiphene citrate and Estradiol	Maher elesawi kamel elesawi	marketed	Selective estrogen receptor modulator (SERM) combined with estrogen replacement	Estrogen receptor alpha and beta
Metformin plus clomiphene citrate	Metformin plus clomiphene citrate	University Magna Graecia	marketed	Combination therapy: biguanide + selective estrogen receptor modulator (SERM)	Insulin signaling pathway (metformin); estrogen receptor (clomiphene citrate)
raloxifene HCI and alendronate Na	raloxifene HCI and alendronate Na	Eli Lilly and Company	marketed	Selective estrogen receptor modulator (SERM) + bisphosphonate combination	Estrogen receptor (raloxifene); osteoclast farnesyl pyrophosphate synthase (alendronate)
Bazedoxifene/Conjugated Estrogen	Bazedoxifene/Conjugated Estrogen	University of North Carolina, Chapel Hill	marketed	Selective Estrogen Receptor Modulator (SERM) combined with Conjugated Estrogens	Estrogen receptor alpha (ERα) and estrogen receptor beta (ERβ)

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Selective estrogen receptor modulator (SERM) class)

1. University Hospital, Basel, Switzerland · 2 drugs in this class
2. AstraZeneca · 2 drugs in this class
3. Estetra · 1 drug in this class
4. Fundació Privada Eugin · 1 drug in this class
5. H. Lee Moffitt Cancer Center and Research Institute · 1 drug in this class
6. National Taiwan University Hospital · 1 drug in this class
7. Oregon Health and Science University · 1 drug in this class
8. Samsung Medical Center · 1 drug in this class
9. Shandong Suncadia Medicine Co., Ltd. · 1 drug in this class
10. Sheba Medical Center · 1 drug in this class