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Cyclofem
Cyclofem is a Small molecule drug developed by Chulalongkorn University. It is currently in Phase 1 development. Also known as: Questionnaire and Menstrual record chart, Cyclofem.
Cyclofem is a form of combined injectable birth control that contains estradiol cypionate and medroxyprogesterone acetate. It is administered once a month by injection into a muscle and is recommended for short-term use.
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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).
| 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 | Cyclofem |
|---|---|
| Also known as | Questionnaire and Menstrual record chart, Cyclofem |
| Sponsor | Chulalongkorn University |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Home-based Delivery of the Contraceptive Implant in Postpartum Guatemalan Women (NA)
- HIV-Target Cell Response in Women Initiating Various Contraceptive Methods in High HIV-Incidence Areas: Zim CHIC
- Pharmacokinetic and Pharmacodynamic Study of Cyclofem (PHASE1, PHASE2)
- The Effect of Cyclofem® for the Treatment of Irregular Uterine Bleeding in Implant Contraceptive Users (PHASE1, PHASE2)
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:
- Cyclofem CI brief — competitive landscape report
- Cyclofem updates RSS · CI watch RSS
- Chulalongkorn University portfolio CI
Frequently asked questions about Cyclofem
What is Cyclofem?
Who makes Cyclofem?
Is Cyclofem also known as anything else?
What development phase is Cyclofem in?
Related
- Manufacturer: Chulalongkorn University — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Questionnaire and Menstrual record chart, Cyclofem
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing